Ingestion-related biofeedback and personalized medical therapy method and system

ABSTRACT

A system including a sensor, a mobile device, and a computer system is disclosed. The sensor is configured to detect physiologic data from the body of the patient. The mobile device includes a patient data input device. The computer system, communicatively coupled to the mobile device, includes a patient record indicating: patient data comprising a plurality of patient activities, and detected physiological data received from the sensor via the mobile device. The computer system is configured to identify an unhealthy physiological data value from the detected physiological data of the patient record, correlate the unhealthy physiological data value to a patient activity of the patient data, select a therapeutic recommendation to address the unhealthy physiological data value, and transmit the selected therapeutic recommendation to the patient, via the mobile device, at a future time associated with the patient activity correlated to the unhealthy physiological data value.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of both U.S. Provisional PatentApplication No. 61/142,869, filed on Jan. 6, 2009, titled“Ingestion-Related Biofeedback Method and System”; and U.S. ProvisionalPatent Application No. 61/260,325, filed on Nov. 11, 2009, titled“Method and System for Personalized Medical Therapy”, both of whichapplications are incorporated by reference in their entirety for allpurposes in the Present Application.

INTRODUCTION

The present invention relates generally to medical therapy systems,devices, and methods. More specifically, the invention relates tosystems, devices, and methods for applying information related to aningestion by a patient of a device, medication or substance.

Proper adjustment of medical treatment is an important factor in thesuccess of medical therapies. Although some conclusions regarding theefficacy of treatment may be drawn from analysis of the patient's directsensory symptoms during treatment and used as a modification indicator,many conditions exist where the patient has little direct sensoryawareness. Hypertension is one such disease state. Patient adherence isanother important factor in the success of medical therapies. Reliableadherence information may be used to inform efficacy and modificationdeterminations. Lack of reliable adherence information, however, may bean issue. Adherence information may not be available. Further, adherenceinformation may be faulty, inaccurate, or inadequate. Poorly informedmedical treatment decisions, for example, those made in the absence ofcomprehensive, adherence information, may result in suboptimal therapyprograms. Such programs may result in loss of quality of life, loss inhealth, and/or loss of life span.

Biofeedback is one technique that can be used to adjust medicaltreatment and to encourage patient adherence to medical therapy.Biofeedback may be defined as the technique of revealing certainselected internal physiologic indicators of physical health bypresenting verbal, textual, visual and/or auditory signals to amonitored person in order to help the monitored person to manipulatethese otherwise involuntary, unfelt and/or little felt vital processes(such as blood pressure, heart beat and respiration rate and intensity).Biofeedback techniques can enable a person to modify a monitoredphysiologic indicator to achieve, or more consistently maintain, ahealthy condition. Achieving such health management goals typicallyrequires voluntary cooperation on the part of the subject.

The management of certain chronic diseases or ongoing health conditions,hypertension for example, can be supported by monitoring and controllingone or more vital aspects of a patient. Examples of these diseasecontrol parameters include blood glucose of diabetes patients,respiratory flow of asthma sufferers, blood pressure of hypertensivepatients, cholesterol of cardiovascular disease victims, body weight ofeating disorder patients, T-cell or viral count of HIV bearers, andfrequency or timing of undesirable episodes of depression of mentalhealth patients. Because of the continuous nature of these diseases,clinicians can gain valuable information by monitoring one or more vitalhealth processes on a regular basis outside of a clinical care facility.

A patient may monitor and control one or more vital health parameters inclinician assisted self-care or outpatient treatment programs. The term“health parameter” refers to any parameter associated with health, e.g.,the health of a patient, athlete, or other living being. In thesetreatment programs, patients are responsible for performing self-careactions which impact the control parameter. Patients are alsoresponsible for measuring the control parameter to determine the successof the self-care actions and the need for further adjustments. Thesuccessful implementation of such a treatment program requires a highdegree of motivation, training, and understanding on the part of thepatients to select and perform the appropriate self-care actions. Whenreliable, useful guidance is provided to the patient in a timely manner,the patient's confidence may increase in the health improvement program.With an increase in confidence, the patient may be more likely to adhereto the health improvement program. Adherence, in turn, increases thelikelihood of success of the health improvement program.

Further, ingestible pharmaceutical agents, for example, prescription andnon-prescription medicines and substances can be an important aspect ofa therapeutic regime prescribed to a given patient. Reliable monitoringof adherence to scheduled dosages of pharmaceutical agents is desirableto optimize biofeedback effectiveness.

There is a long-felt need to provide behavioral guidance developed inview of various physiologic parameters and longitudinal monitoring ofvital health aspects of the patient.

SUMMARY

The present disclosure seeks to address at least some of the previouslydiscussed problems. The present disclosure includes methods and systemsfor acquiring information useful to support a patient in implementingand adhering to a medically prescribed therapy plan. The therapy mayincorporate biofeedback methods and/or personalized therapy aspects.

A method includes steps of acquiring biometric information associatedwith an ingestible event marker; analyzing, by a computing device havinga microprocessor configured to perform a biometric information analysis,the biometric information; and determining a therapeutic recommendationat least partly on the basis of the analysis. The method furtheroptionally includes integrating biofeedback techniques into patienttherapy and/or activity.

A system includes a biometric information module to acquire informationassociated with an ingestible event marker; an analysis module toanalyze the information; and a determination module to optionallydetermine and communicate a therapeutic recommendation to a patient atleast partly on the basis of the analysis of the information.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

Such incorporations include U.S. Patent Application Publication No.20080284599 published on Nov. 20, 2008 titled “Pharma-InformaticsSystem”; U.S. Patent Application Publication No. 20090135886 titled“Transbody Communication Systems Employing Communication Channels”, U.S.Patent Application No. 20090082645, published on Mar. 26, 2009 titled“In-Body Device With Virtual Dipole Signal Amplification”; U.S. patentapplication Ser. No. 12/546,017 filed Sep. 21, 2009 titled,“Communication System With Partial Power Source”; U.S. ProvisionalPatent Application No. 61/251,088 filed Oct. 13, 2009 titled “Receiverand Method”; and U.S. Provisional Patent Application No. 61/034,085,filed Mar. 5, 2008.

Such incorporations further include Patent Applications filed under thePatent Cooperation Treaty (“PCT”), to include PCT Patent ApplicationSerial No. PCT/US2006/016370, filed Apr. 28, 2006; PCT PatentApplication Serial No. PCT/US07/82563, filed Oct. 17, 2007; PCT PatentApplication Serial No. PCT/US2008/52845 filed Feb. 1, 2008; PCT PatentApplication Serial No. PCT/US2006/016370 published as WO/2006/116718;PCT Patent Application Serial No. PCT/US2007/082563 published asWO/2008/052136; PCT Patent Application Serial No. PCT/US2007/024225published as WO/2008/063626; PCT Patent Application Serial No.PCT/US2007/022257 published as WO/2008/066617; PCT Patent ApplicationSerial No. PCT/US2008/053999 published as WO/2008/101107; PCT PatentApplication Serial No. PCT/US2008/056296 published as WO/2008/112577;PCT Patent Application Serial No. PCT/US2008/056299 published asWO/2008/112578; and PCT Patent Application Serial No. PCT/US2008/077753.

The publications discussed or mentioned herein are provided solely fortheir disclosure prior to the filing date of the present application.Nothing herein is to be construed as an admission that the presentinvention is not entitled to antedate such publication by virtue ofprior invention. Furthermore, the dates of publication provided hereinmay differ from the actual publication dates which may need to beindependently confirmed.

BRIEF DESCRIPTION OF THE FIGURES

These, and further features of various aspects of the present invention,may be better understood with reference to the accompanyingspecification, wherein:

FIG. 1 is a schematic of an electronic communications networkcommunicatively coupled with an IEMD, a patient management data systemand one or more vital parameter sensors.

FIG. 2 is a schematic of the patient management data system of FIG. 1.

FIG. 3 is a schematic diagram of a system software of the patientmanagement data system of FIGS. 1 and 2.

FIG. 4A is an illustration of a representative first patient record asstored in the patient management data system or elsewhere in the networkof FIG. 1.

FIG. 4B is an illustration of a representative first medication recordas stored in the patient management data system or elsewhere in thenetwork of FIG. 1.

FIG. 4C is an illustration of a representative first behaviorrecommendation record as stored in the patient management data system orelsewhere in the network of FIG. 1.

FIG. 4D is an illustration of a representative patient history data ofthe first patient record of FIG. 4A.

FIG. 5 is an illustration of additional aspects of the method of thepresent invention, wherein a patient is treated for a health conditionby means of the electronic communications network, the IEMD, the patientmanagement data system and one or more vital parameter sensors of FIGS.1 and 2.

FIG. 6 is an illustration of other aspects of the method of the presentinvention, wherein certain behaviors of the patient and interaction ofthe patient with the patient management data system of FIGS. 1 and 2 isdenoted.

FIG. 7 is an illustration of a process implemented by the patientmanagement data system of FIGS. 1, 2 and 3 in communication with thenetwork, IEMD and sensors of FIG. 1.

FIG. 8 is a process chart of a method in which a clinician or an expertsystem monitors a vital parameter of the patient and suggest via thenetwork of FIG. 1 a therapeutic behavior intended to improve the healthof the patient.

FIG. 9 is a process chart of a method of the patient management datasystem to determine if and when to send a text or audio message to thepatient transceiver and/or the patient input device of FIG. 1.

FIG. 10 is another process chart of a method of the patient managementdata system to determine if and when to send a text or audio message tothe patient transceiver and/or the patient input device of FIG. 1.

FIG. 11 shows an exemplary process flow.

FIG. 12 is a schematic of a patient coupled with a plurality ofbiometric sensors and in communication with a cellular telephone, othermobile computational devices and information technology networks.

FIG. 13 is an illustration of a display screen of the cellular telephoneof FIG. 12 displaying icons.

FIG. 14 is a schematic diagram of the cellular telephone of FIGS. 12 and13.

FIG. 15 is a schematic diagram of a mobile phone system software of thecellular telephone of FIGS. 12, 13 and 14.

FIG. 16 illustrates a first disclosed exemplary additional or alternateprocess, wherein the cellular telephone of FIG. 12-15 displays one ormore icons of FIG. 13.

FIG. 17A is an illustration of an exemplary record that includes an iconidentifier relating to an icon of FIG. 13.

FIG. 17B is an illustration of log event data that contain biometricinformation generated and transmitted by a biometric sensor of FIG. 12.

FIG. 18 illustrates a graph 114 wherein a plurality of event log data ofFIG. 6A and a plurality of biometric data of FIG. 17B are displayed on adisplay screen of FIGS. 12, 13 and 14.

FIG. 19 is an illustration of an additional or alternate method whereinthe cellular telephone of FIGS. 12-15 transmits information via thenetwork to the data base system and/or the diagnostic system of FIG. 12.

FIG. 20 is an illustration of an additional or alternate method, whereinthe cellular telephone of FIGS. 12-15 receives information via thenetwork from the data base system and/or the diagnostic system of FIG.12.

FIG. 21 illustrates a still other additional or alternate method,wherein global positioning data (hereinafter “GPS data”) collected fromthe cellular telephone of FIGS. 12-15 of the patient of FIG. 12 are usedto determine the current and relative level of social interaction inwhich the patient is engaging.

FIG. 22 illustrates yet another additional or alternate method, whereina diagnostician applies an activity monitor logic of the diagnosticsystem of FIG. 12.

FIG. 23 is a schematic of a diagnostic system software of the diagnosticsystem of FIG. 12.

FIGS. 24A, 24B and 24C are schematics of information stored in thediagnostic system of FIGS. 12 and 23.

FIG. 25 illustrates a still other additional or alternate method,wherein GPS data collected from the cellular telephone of FIGS. 12-15 ofthe patient of FIG. 12 are used to determine the current and relativelevel of social interaction in which the patient is engaging.

FIG. 26 is an illustration of yet another additional or alternatemethod, wherein a diagnostician applies a mobility monitor logic of thediagnostic system of FIGS. 12 and 23 to generate a GPS data baseline(hereinafter “GPS baseline”).

FIG. 27 is a process chart of an even other additional or alternatemethod, wherein the cellular telephone of FIGS. 12-15 is programmed torender a distinctive ringtone, alarm tone, audio message, and/or textmessage to alert the patient of FIG. 1 to take a medication, engage in amedically recommended behavior, or cease a behavior.

FIG. 28 illustrates a still further additional or alternate method,wherein the phone of FIGS. 12-15 is programmed to remind the patient ofFIG. 12 to take, e.g., ingest, inhale, insert, or topically apply, oneor more medications of FIG. 12.

FIG. 29 is a schematic of a first exemplary patient record selected froma plurality of patient records that are stored in the cellular telephoneof FIGS. 12-15, the DB computer of FIG. 12, and/or the diagnostic systemof FIGS. 12 and 23.

FIG. 30 illustrates an even other additional or alternate method,wherein a patient record is applied by the phone of FIGS. 12-15 torecord biometric data received from one or more sensors of FIG. 1 and tosend reminding alerts to encourage the patient of FIG. 1 to performmeditative exercises, relaxation exercises, or other therapeutic orprescribed behaviors.

FIG. 31 describes another additional or alternate method, wherein highstress events that occur routinely in the routine life of the patientare identified and the phone of FIGS. 12-15 is programmed to encouragethe patient of FIG. 12 to take therapeutic steps to reduce the harmfulimpact of the stress inducing events.

FIG. 32 is a schematic of an exemplary patient activity log.

FIG. 33 describes a yet other alternate or additional method, whereinthe diagnostician analyzes information about diagnostic test results,genetic test results, patient records, patient activity logs, and otherinformation to develop and prescribe therapy.

FIG. 34 is a schematic of an exemplary first diagnostic test record thatincludes a patient identifier, a phone identifier, and a plurality ofdiagnostic test notes.

FIG. 35 is a schematic of an exemplary first genetic test record thatincludes the patient identifier of FIG. 34, the phone identifier, and aplurality of genetic test notes.

FIG. 36 is a schematic illustrating the diagnostic system software ascontaining patient records, diagnostic records and genetic records.

FIG. 37 is a schematic of the patient of FIG. 12 being monitored byadditional sensors.

FIG. 38 is a schematic diagram of the exemplary heart rate sensor ofFIG. 12.

FIG. 39 illustrates another still additional or alternate method,wherein a diagnostician receives and analyzes information and advisesthe patient of FIGS. 12-15 and 37 with therapeutic guidance.

FIG. 40 illustrates another even additional or alternate method, whereinthe patient of FIGS. 12 and 37 is encouraged by yet other engagementmodalities to adhere to a prescribed ingestion of the medicine of FIG.12.

FIG. 41 illustrates another even additional process wherein the patchreceiver of FIG. 12 is attached or coupled to the patient of FIG. 12 andmonitored over two separate time periods.

FIG. 42 illustrates a system to facilitate adherence to a treatmentplan.

FIG. 43 illustrates a system to facilitate adherence to a treatment planincluding a patient management system communicatively coupled with allother parts via a communications bus.

DETAILED DESCRIPTION

While the present invention has been described with reference tospecific methods, devices and systems, it should be understood by thoseskilled in the art that various changes may be made and equivalents maybe substituted without departing from the true spirit and scope of theinvention. In addition, many modifications may be made to adapt aparticular situation, material, composition of matter, process, processstep or steps, to the objective, spirit and scope of the presentinvention. All such modifications are intended to be within the scope ofthe claims appended hereto.

Methods recited herein may be carried out in any order of the recitedevents which is logically possible, as well as the recited order ofevents.

Where a range of values is provided herein, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the invention. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges and are also encompassed within the invention, subject toany specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits ranges excluding either or bothof those included limits are also included in the invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present invention, the methodsand materials are now described.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. It is further noted that the claimsmay be drafted to exclude any optional element. As such, this statementis intended to serve as antecedent basis for use of such exclusiveterminology as “solely,” “only” and the like in connection with therecitation of claim elements, or use of a “negative” limitation.

Referring now generally to the Figures and particularly to FIG. 1, FIG.1 is a schematic of an electronic communications network 2communicatively coupled with an ingestible device 4 (hereinafter “IEMD”4) wherein the IEMD 4 has been ingested within a patient's body 6. Apatient transceiver 8 is configured to receive a wireless transmissionfrom the IEMD 4 that includes an ingestible event datum M, or “IEM M”.Alternatively, the patient transceiver 8 may be configured to acquirecommunicated information comprising an IEM M, or a datum of an IEM M,via the electronic communications network 2 or an aspect device orsource 6-24 communicatively coupled with or comprised within theelectronic communications network 2.

The IEMD 4 gathers, collects, and/or generates ingestion data viavarious methods, e.g., ingestion timing, contact with alimentary systemsubstances, sampling, etc. Further, various ingestible event marker datasource devices IEMD 4 communicate the IEM M data via various methods,e.g., wireless methods, conductive methods via body tissue, etc. Thefollowing are examples of the ingestible devices 300 a.

A pharma-informatics system described in PCT/US2006/016370, filed Apr.28, 2006, includes compositions, systems and methods that allow for thedetection of the actual physical delivery of a pharmaceutical agent tothe body 6 are provided. Embodiments of the compositions include anidentifier and an active agent.

A system described in PCT/US2008/52845, filed Feb. 1, 2008, includes anIEMD 4 referred to therein as an ingestible event marker IEM and patienttransceiver 8 referred to therein as a personal signal receiver. Aspectsof data transmitted from the IEMD 4 may include an identifier, which mayor may not be present in a physiologically acceptable carrier. Theidentifier is characterized by being activated upon contact with atarget internal physiological site of the body 6, such as digestivetract internal target site. The patient transceiver 8 may be configuredto be associated with a physiological location, e.g., inside of or onthe body 6, and to receive a signal from the IEMD 4. During use, theIEMD 4 broadcasts a signal which is received by the patient transceiver8.

The ingestion data associated with the electronic communications network2 (hereinafter “network” 2) include personal patient data, e.g.,physiologic data generated by the IEMD 4. Examples are derived metrics,e.g., processed physical data to derive various metrics such as time ofingestion data; combined metrics, e.g., derived metrics combined withother derived metric data such as time of ingestion data combined withdata identifying the ingested substance; and patient data, e.g., derivedmetrics and/or combined metrics aggregated with various physiologic datasuch as time of ingestion data combined with data identifying theingested substance and physiologic data such as ECG data, temperature,etc.

A controlled activation ingestible identifier described in PCT PatentApplication PCT/US07/82563, filed Oct. 17, 2007, includes ingestiblecompositions such as pharma-informatics enabled compositions. Thecontrolled activation ingestible identifiers include a controlledactivation element that provides for activation of the identifier inresponse to the presence of a predetermined stimulus at a target site ofinterest.

A life cycle pharma informatics system described in U.S. PatentProvisional Application Ser. No. 61/034,085, filed Mar. 5, 2008 includesRFID and conductive communications technology combined with medicationand/or medication packaging such that the medication can be tracked forthe duration of its existence. The system further allows in-body datatransmissions while addressing the potential privacy and signaldegradation concerns associated with RFID technology.

Additional examples of ingestible identifiers of interest include thosedescribed in Examples of different types of identifiers of interestinclude, but are not limited to, those identifiers described in PCTapplication serial no. PCT/US2006/016370 published as WO/2006/116718;PCT Patent Application Serial No. PCT/US2007/082563 published asWO/2008/052136; PCT Patent Application Serial No. PCT/US2007/024225published as WO/2008/063626; PCT Patent Application Serial No.PCT/US2007/022257 published as WO/2008/066617; PCT Patent ApplicationSerial No. PCT/US2008/052845 published as WO/2008/095183; PCT PatentApplication Serial No. PCT/US2008/053999 published as WO/2008/101107;PCT Patent Application Serial No. PCT/US2008/056296 published asWO/2008/112577; PCT Patent Application Serial No. PCT/US2008/056299published as WO/2008/112578; and PCT Patent Application Serial No.PCT/US2008/077753; the disclosures of which are herein incorporated byreference.

The patient transceiver 8 may be or comprise an electroniccommunications device configured for receipt of wireless transmissionsfrom the IEMD 4 and optionally comprising, for example, (a.) aninformation appliance; (b.) a television set-top box; (c.) a VAIO FS8900(™) notebook computer marketed by Sony Corporation of America, of NewYork City, N.Y., (d.) a SUN SPARCSERVER (™) computer workstationmarketed by Sun Microsystems of Santa Clara, Calif. and running a LINUX(™) or a UNIX (™) operating system; (e.) a wireless communicationsenabled personal computer configured for running WINDOWS XP (™) or VISTA(™) operating system marketed by Microsoft Corporation of Redmond,Wash.; (f.) a PowerBook G4 (™) personal computer as marketed by AppleComputer of Cupertino, Calif.; (g.) an iPhone (™) cellular telephone asmarketed by Apple Computer of Cupertino, Calif.; and/or (h.) a personaldigital assistant enabled for wireless communications.

The electronic communications network 2 may be or comprise, for example,in whole or in part, a telephony network 2A, a wireless communicationsnetwork, a computer network, and/or the Internet 2B.

The patient transceiver 8 is communicatively coupled with a patientmanagement data system 10 (hereinafter, “PMDS” 10) via the electronicscommunications network 2. The patient transceiver 8 may becommunicatively coupled with the electronics communications network 2(hereinafter, “the network” 2) by a hard wire connection and/or awireless communications mode with a first network transceiver 12,wherein the first network transceiver 12 is communicatively coupled withthe network 2 by a hard wire connection.

A patient messaging module 14 is additionally coupled with the network2, wherein the patient messaging module 14 enables a clinician or anautomated information system (not shown) to transmit recommendations tothe patient regarding medicinal ingestion, patient behavior andtherapeutic activity. The patient messaging module 14 and/or the PDMStransceiver 8 may be communicatively coupled with the network 2 by meansof a hard wire connection and/or a wireless communications mode with asecond network transceiver 16, wherein the first network transceiver 12is communicatively coupled with the network 2 by a hard wire connection.

It is understood that the patient messaging module 14 may be comprisedwithin the PMDS 10, and that the patient messaging module 14 and/or thePMDS 10 may comprise or be comprised within a unified or distributedelectronic information technology system configured for communicationvia the network 2 and optionally comprising, for example, (a.) aninformation appliance; (b.) a television set-top box; (c.) a VAIO FS8900(™) notebook computer marketed by Sony Corporation of America, of NewYork City, N.Y., (d.) a SUN SPARCSERVER (™) computer workstationmarketed by Sun Microsystems of Santa Clara, Calif. and running a LINUX(™) or a UNIX (™) operating system; (e.) a wireless communicationsenabled personal computer configured for running WINDOWS XP (™) or VISTA(™) operating system marketed by Microsoft Corporation of Redmond,Wash.; (f.) a PowerBook G4 (™) personal computer as marketed by AppleComputer of Cupertino, Calif.; (g.) a mobile or cellular digitaltelephone; (h.) an iPhone (™) cellular telephone as marketed by AppleComputer of Cupertino, Calif.; and/or (i.) a personal digital assistantenabled for wireless communications.

A patient input device 18 is additionally coupled with the network 2,wherein the patient input device 18 enables a patient or caregiver (notshown) to transmit reports and information regarding patient adherenceor non-adherence to recommended therapy; patient behavior; patientphysical, mental, or emotional condition; risk taking or risk seekingbehavior by the patient; and therapeutic activity of the patient. Thepatient input device 18 may be included within the patient transceiver8, and/or may comprise or be comprised within an electroniccommunications device, or a unified or distributed electronicinformation technology system configured for communication via thenetwork 2 and optionally comprising, for example, (a.) an informationappliance; (b.) a television set-top box; (c.) a VAIO FS8900 (™)notebook computer marketed by Sony Corporation of America, of New YorkCity, N.Y., (d.) a SUN SPARCSERVER (™) computer workstation marketed bySun Microsystems of Santa Clara, Calif. and running a LINUX (™) or aUNIX (™) operating system; (e.) a wireless communications enabledpersonal computer configured for running WINDOWS XP (™) or VISTA (™)operating system marketed by Microsoft Corporation of Redmond, Wash.;(f.) a PowerBook G4 (™) personal computer as marketed by Apple Computerof Cupertino, Calif.; (g.) an iPhone (™) cellular telephone as marketedby Apple Computer of Cupertino, Calif.; (h.) an iPhone (™) cellulartelephone as marketed by Apple Computer of Cupertino, Calif.; and/or(i.) a personal digital assistant enabled for wireless communications.

A first vital parameter monitor 20, or “first sensor” 20, is coupledwith the patient's body 6 and may be or comprise, for example, a motiondetector, a heart rate monitor, a blood pressure monitor, a respirationmonitor, and/or a patient skin electrical current conductivity monitor.A second vital parameter monitor 22, or “second sensor” 22, is coupledwith the patient's body 6 and may additionally be or comprise, forexample, a motion detector 23, a heart rate monitor, a blood pressuremonitor, a respiration monitor, and/or a patient skin electrical currentconductivity monitor.

The motion detector 23 is communicatively coupled to the analysis moduleand the PMDS 10 whereby the PMDS 10 incorporates a patient motion datumgenerated by and communicated from the motion detector 23 in an analysisof at least one health parameter of a patient. The motion detector 23may be, comprise, or comprised within, for example, a cellulartelephone, an accelerometer and/or a global positioning signal device.

A third vital parameter monitor 24 is positioned remotely from thepatient's body 6, and is configured to monitor a vital parameter of thepatient's body 6 by remote sensing, for example, sound detection, airpressure variation, light energy reflection, and/or heat detection. Thethird sensor 24 may be or comprise a motion detector, for example, aheart rate monitor, a blood pressure monitor, a respiration monitor,and/or a patient skin electrical current conductivity monitor.

A system described in PCT/US2008/52845, filed Feb. 1, 2008, includes anIEMD 4 referred to therein as an ingestible event marker IEMD 4 andpatient transceiver 8 referred to therein as a personal signal receiver.Aspects of IEM M data transmitted from the IEMD 4 and/or sensors 20, 22,23 and 24 may include an identifier (sometimes, for example, referred toherein as an “ingestible event marker”, an “ionic emission module”,and/or an “IEM”), which may or may not be present in a physiologicallyacceptable carrier. The identifier is characterized by being activatedupon contact with a target internal physiological site of a body, suchas digestive tract internal target site. The patient transceiver 8 maybe configured to be associated with a physiological location, e.g.,inside of or on the body, and to receive a signal from the IEMD 4 and/orsensors 20, 22, 23 and 24. During use, the IEMD 4 and/or sensors 20, 22,23 and 24 broadcasts signals that are received by the patienttransceiver 8.

The ingestion data associated with the network 2 include personal data,e.g., physiologic data generated by the IEMD 4 and/or sensors 20, 22, 23and 24. Examples are derived metrics, e.g., processed physical data toderive various metrics such as time of ingestion data; combined metrics,e.g., derived metrics combined with other derived metric data such astime of ingestion data combined with data identifying the ingestedsubstance; and patient data, e.g., derived metrics and/or combinedmetrics aggregated with various physiologic data such as time ofingestion data combined with data identifying the ingested substance andphysiologic data such as ECG data, temperature, etc.

A controlled activation ingestible identifier described inPCT/US07/82563, filed Oct. 17, 2007, includes ingestible compositionssuch as pharma-informatics enabled compositions. The controlledactivation ingestible identifiers include a controlled activationelement that provides for activation of the identifier in response tothe presence of a predetermined stimulus at a target site of interest.

A life cycle pharma informatics system described in U.S. PatentApplication Ser. No. 61/034,085, filed Mar. 5, 2008 includes RFID andconductive communications technology combined with medication and/ormedication packaging such that the medication can be tracked for theduration of its existence. The system further allows in-body datatransmissions while addressing the potential privacy and signaldegradation concerns associated with RFID technology.

The computer architecture shown in FIG. 2 illustrates the aspects of thePMDS 10, including a central processing unit 26 (hereinafter, “CPU”), asystem memory 28, including a random access memory 30 (hereinafter,“RAM”) and a read-only memory (hereinafter, “ROM”) 32, and a power andcommunications system bus 34 that couples the system memory 28 to theCPU 26. A basic input/output system 36 containing the basicsoftware-encoded instructions and routines that help to transferinformation between elements within the PMDS 10, such as during startup,is stored in the ROM 20. The PMDS 10 further includes a system software38 and a database management system 40 (hereinafter “DBMS” 40), whichwill be described in greater detail below, stored in the system memory28 and/or a computer-readable medium 42.

A media writer/reader 44 is bi-directionally communicatively coupled tothe CPU 26 through the power and communications system bus 34(hereinafter “the bus” 34). The media writer/reader 44 and theassociated computer-readable media 42 are selected and configure toprovide non-volatile storage for the PMDS 10. Although the descriptionof computer-readable media 42 contained herein refers to a mass storagedevice, such as a hard disk or CD-ROM drive, it should be appreciated bythose skilled in the art that computer-readable media can be anyavailable media that can be accessed by the PMDS 10.

By way of example, and not limitation, computer-readable media 42 maycomprise computer storage media and communication media. Computerstorage media includes volatile and non-volatile, removable andnon-removable media implemented in any method or technology for storageof information such as computer-readable instructions, data structures,program modules or other data. Computer storage media includes, forexample, but is not limited to, RAM, ROM, EPROM, EEPROM, flash memory orother solid state memory technology, CD-ROM, digital versatile disks(“DVD”), or other optical storage, magnetic cassettes, magnetic tape,magnetic disk storage or other magnetic storage devices, or any othermedium which can be used to store the desired information and which canbe accessed by the PMDS 10.

The computer-readable medium 42 may comprise machine-readableinstructions which when executed by the PMDS 10 to cause the PMDS 10 toperform one or more steps as described in the Figures and enabled by thepresent disclosure. The bus 34 further bi-directionally communicativelycouples a network interface 46, a user input interface 48, a user audioinput interface 50, and a video screen interface 52 with the CPU 26 andthe system memory 28. The video screen interface 52 directs visualpresentations of data on a visual display screen 54 and bi-directionallycommunicatively couples the visual display screen 54 with the CPU 26 viathe communications bus 34. The user input interface 48 couples a userinput device 56, for example, an electronic keyboard, a computer mouse,a computer trackball, or a computer mouse pad, with the CPU 26 via thecommunications bus 34 and enables the clinician to input iconselections, commands and data to the PMDS 10. The icon selections may bechosen from images presented on the visual display screen 54.

The audio input interface 50 couples a user audio input device 58, forexample an audio microphone, with the CPU 26 via the communications bus34 and enables the clinician to input vocal input that communicates iconselections, commands and data to the PMDS 10, and/or digitizedrepresentations of verbal expressions. The digitized representations ofverbal expressions may be transmitted via the network interface 46 toenable VoIP communications with the patient input device 18 and/or thepatient transceiver 8.

An audio output interface 60 communicatively coupled with thecommunications bus 34 receives digitized verbal information, forexample, VoIP messages, from the network 2 via the network interface 46and drives the audio output device 62 to audibly output verbal messagederived from the digitized verbal communications.

An audio/text converter module 64 (a.) converts digitized audio datainto textual data for storage in a patient record R.0; and (b.) convertstext data into audio data representative of vocalizations of the sourcetext data. The converted text data may be received via the bus 34 andfrom the system memory 28 or the network 2, or generated by the CPU 26.

A wireless interface 66 enables bi-directional communication between thebus 34 and a wireless transceiver 68, whereby the PMDS 10 maycommunicate via the wireless and/or hard wired telephony network 2A withan element 8-16 to the network 2.

It is understood that the additional elements 8 and 12-16 of the network2 may include one, several or all of the aspects 26-68 of the PMDS 10.It is further understood that the PMDS 10 may optionally, additionallyor alternatively be configured to acquire a communicated informationcomprising an IEM M, or a datum of an IEM M, via the electroniccommunications network 2 or an aspect device or source 6-24communicatively coupled with or comprised within the electroniccommunications network 2.

FIG. 3 is an illustration of the system software 38 of the PMDS 10 ofFIGS. 1 and 2. An operating system 70 enables a VOIP client softwaremodule 72 to provide voice data to the network 2 by directing the audioinput driver 74 to digitize acoustic signals detected by the audio inputdevice 58 to form a digitized voice record and transmit the digitizedvoice record to the patient transceiver 8 and or the patient inputdevice 18 via the network 2. It is understood that the first networktransceiver 12 and/or the second network transceiver 16 may facilitatethe transmission of voice communications between the PMDS 10 and thepatient transceiver 8 and/or the patient input device 18. An audiooutput driver 76 processes digitized acoustic signals received from thenetwork 2 and directs the audio output interface 60 and the audio outputdevice 62 to derive and broadcast acoustic signals from the receiveddigitized acoustic signals for hearing by the clinician.

A display driver 78 directs the video interface 52 and the video screen54 to visually present information received from, or derived from inputsderived from the network 2, the patient transceiver 8, the patient inputdevice 18, the first network transceiver 12, the second networktransceiver 16, a graphical user interface driver 80 of the PMDS 10, theaudio input device 58 and/or the input device 56. A web browser 82 mayenable the PMDS 10 to visually display information received from theInternet 2B. The user record R.0 and a plurality of user records R.1-R.Nare stored in a patient database 84 of the DBMS 40.

A text editor 86 and an email client 87 separately or in combinationenable the clinician to, for example, prepare text messages, and/or toinclude reminder messages for medication ingestion, for transmission viathe network 2 and to the patient transceiver 8 and or the patient inputdevice 18. It is understood that the first network transceiver 12 and/orthe second network transceiver 16 may facilitate the transmission oftext messages between the PMDS 10 and the patient transceiver 8 and/orthe patient input device 18.

It is understood that the additional elements 8 and 12-16 of the network2 may include one, several or all of the software aspects 70-86 of thePMDS 10.

Referring now generally to the Figures and particularly to FIG. 4A, FIG.4A is an illustration of the representative first patient record R.0 theformat of which may be followed in whole or in part by one or more ofthe remaining patient records R.1-R.N. A first record identifier R.0.IDuniquely identifies the first record R.0 within the PMDS 10 and apatient identifier R.0.PID identifies the patient associated with thefirst record R.0. A network patient address R.0.ADDR identifies anetwork address of the patient transceiver 8 and/or the patient inputdevice 18 to which electronic messages, for example, email messages, maybe sent. A patient telephone number R.0.ADDR.T identifies a telephonenumber used to establish a telephonic communications session duringwhich a text message or a voice communication maybe accomplished. One ormore medication records R.0.MR.0-R.0.MR.N specify one or more medicinesprescribed to the patient. A medication reminder flag R.0.FM indicateswhether the patient is to be reminded by the PMDS 10 to ingest orotherwise apply a medication. One or more behavior recordsR.0.BHR.0-R.0.BHR.N specify one or more behaviors prescribed to thepatient. A behavior remind flag R.0.FB indicates whether the patient isto be reminded by the PMDS 10 to engage in (or to avoid) a specifiedbehavior. A patient history data retains information associated with thepatient and may include records of receipt of attestations from thepatient and receipt of ingestible event data IEM M. A patient activitydata R.ACT retains information describing expected types of patientactivities and expected times of the patients may be engaging in eachexpected activities.

Referring now generally to the Figures and particularly to FIG. 4B, FIG.4B is an illustration of the representative first medication recordR.0.MR.0. A first medication record identifier RM.ID uniquely identifiesthe first medication record R.0.MR.0 within the PMDS 10, and the patientidentifier R.0.PID identifies the patient associated with the firstmedication record R.0.MR.0. A medication identifier MED.ID identifiesthe medication and dosage thereof associated with the first medicationrecord R.0.MR.0. A dosage data MED.D indicates what dosage of theidentified medication is to be ingested or applied.

An application schedule MED.S indicates when the associated medicationis prescribed to be ingested or otherwise applied. A first remind flagFLAG1 indicates if the patient shall be reminded to apply or ingest theassociated medication before the next prescribed time, wherein thereminder may be sent at approximately a first remind time period TR1before the next prescribed time. A first remind medication text TXT1(hereinafter, “first remind text” TR1) is a prerecorded text messagethat may be sent prior to the scheduled time of ingestion or applicationas a reminder message to the patient to encourage ingesting or applyingthe associated medication.

A second remind flag FLAG2 indicates if the patient shall be reminded toingest the medication associated with the first medication recordR.0.MR.0 in the event that an ingestion event datum IEM M has not beenreceived by the network 2 within a second remind TR2 time after aprescribed ingestion time has passed. A second remind text TXT2 is aprerecorded text message that may be sent after a scheduled time as areminder message to the patient to encourage ingesting or applying theassociated medication identified by the medication identifier MED.0.

Referring now generally to the Figures and particularly to FIG. 4C, FIG.4C is an illustration of the representative first behavior recordR.0.BHR.0. A first behavior record identifier R.BHR.ID uniquelyidentifies the first behavior record R.0.BHR.0 within the PMDS 10, andthe patient identifier R.0.PID identifies the patient associated withthe first behavior record R.0.BHR.0. A behavior identifier BHR.IDidentifies the behavior associated with the first behavior recordR.0.BHR.0. A behavior description text BHR.D includes a textualdescription of a behavior recommended to be engaged in or avoided. Abehavior application schedule BHR.S indicates when the associatedbehavior is prescribed to be ingested or otherwise applied. A firstbehavior remind flag BFLG1 indicates if the patient shall be reminded toperform or avoid the associated behavior before the next prescribedtime, wherein the reminder may be sent at approximately a TRB1 timeperiod before the next prescribed time. A first behavior text TXT1B is aprerecorded text message that may be sent prior to the scheduled time ofingestion or application as a reminder message to the patient toencourage performing, or alternatively avoided, the behavior identifiedby the behavior identifier BHR.ID.

A second behavior remind flag BFLG2 indicates if the patient shall bereminded to perform, or alternatively avoid, the behavior associatedwith the first behavior record R.0.BHR.0 if an attestation by thepatient has not been received by the network 2 within a time after aprescribed time of performance has passed. A second behavior text TXT2Bis a prerecorded text message that may be sent, for example, after ascheduled time of behavior performance, or alternatively, a behavioravoidance, as a reminder message to the patient to encourage performing,or alternatively avoid performing, the associated behavior identified bythe behavior identifier BHR.ID.

Referring now generally to the Figures and particularly to FIG. 4D, FIG.4D is an illustration of the representative patient history data H.D ofthe first record R.0. The patient history data H.D includes, forexample, (a.) a plurality of marker record H.M0-H.MN of previouslyreceived ingestion markers IEM M, (b.) a plurality of attestationrecords H.PA0-H.PAN containing notations of attestations received fromthe patient, and (c.) a plurality of text message records H.T0-H.TN ofpreviously transmitted text messages sent to the patient transceiver 8and/or the patient input device 18. The received patient attestationrecords H.PA0-H.PAN may include, for example, notations of attestationsof performed behaviors, attestations of applications or ingestions ofmedicines, and/or attestations of avoided behaviors.

Referring now generally to the Figures and particularly to FIG. 5, FIG.5 is an illustration of additional aspects of the method of the presentinvention, wherein a patient is treated for a health condition. In step502 a database record R.0 is initiated in the PMDS 10 identifying thepatient. The patient is evaluated in step 504 and diagnosed in step 506.A patient activity model is generated in step 508 wherein the dailyactivity of the patient is included in a software-encoded portion of thedatabase record R.0. Medications and behaviors are prescribed in step510 and the prescribed medications and behaviors are stored in thedatabase record R.0. The patient is counseled and advised of theprescribed medications and behaviors as stored in the database record Rin step 514.

The receipt of ingestion markers IEM M transmitted from one or moreIEMD's 4 and measurements and transmissions of the sensors 20, 22, 23and 24 are received by the patient transceiver 8 and transmitted to thePMDS 10 via the network 2 and the patient record R.0 is updated with thereceived parametric data in step 516. Attestations by the patient, forexample, of (a.) changes in patient activity varying from the activitymodel of step 508; (b.) adherence and non-adherence to prescribedmedication ingestion schedule by the patient; and (c.) performance andnon-performance of prescribed patient behaviors are received via thepatient input device 18 and by the PMDS 10 via the network 2 in step518.

The information received in steps 516 and 518 are evaluated by aclinician or an expert information technology system (not shown) in step520 in view of other information included in the patient record R.0. Theclinician or the expert information technology system may update thepatient diagnosis in step 522, and may further determine in step 524whether to cease treatment of the patient. When the clinician or expertsystem determines in step 824 that the current treatment cycle of thepatient shall cease, the patient is informed of the cessation oftreatment, and the database record R.0 is updated with a notice oftreatment termination, in step 526. The treatment is ended in step 528.

When the clinician or expert system determines in step 524 that thecurrent treatment cycle of the patient shall continue, the clinician orexpert system determines by analysis of the patient record R.0, or oneor more additional patient records R.0-R.N and optionally inconsultation with the patient, determines in step 530 whether toincrease or decrease medication dosage or frequency. When the clinicianor expert system determines in step 530 to increase or decreasemedication dosage or frequency, the patient is informed of theprescription change and the pharmacy is updated in step 534.

The clinician or expert system determines by analysis of the patientrecord R.0, and optionally in consultation with the patient determinesin step 536 whether to alter prescribed or recommended behaviors. Thepatient is informed in step 538 of any alterations or additions ofprescribed or recommended behaviors.

The PMDS 10 determines by analysis of the patient record R.0, in step542 whether to remind the patient to, for example, ingest or apply amedication, or engage in a prescribed or recommended behavior, and thepatient is reminded in step 542 to, for example, ingest or apply amedicine, or engage in a prescribed or recommended behavior.

Referring now generally to the Figures and particularly to FIG. 6, FIG.6 is an illustration of other aspects of the method of the presentinvention, wherein certain behavior of the patient is denoted. In step602 the patient receives a prescription of medications and behaviors. Itis understood that a prescription of medication may include both themedication to be ingested and a schedule for ingesting the prescribedmedications. The patient reports a schedule of expected activities viathe patient input device 18 to the PMDS 10 in step 604. The schedule ofexpected activities, for example, may include work sessions, such asmanual labor, expense report authoring, staff meetings, customerinteraction periods, negotiations sessions, employee review meetings,sales forecast development, and presentations. The expected activitiesreported by the patient in step 604 are integrated into a patient recordR.0 of the patient database 84 by means of the patient input device 18and the network 2. The patient positions one or more sensors 20, 22, 23and 24 in step 606 to enable the sensors 20, 22, 23 and 24 to detect oneor more vital parameters of the patient. The patient ingests an IEMD 4wherein the IEMD 4 transmits an ingestion report with a marker datum IEMM in step 608. The patient may further adhere to behaviors in step 612as suggested in the prescription received in step 602, and reportadherence in step 612 with suggested behaviors, to include one or moreingestions of an IEMD 4.

The patient may elect to cease following medical advice in step 614, andfor example, to cease ingesting IEMD's 4, may proceed on to reportcessation of adherence to the PMDS 10 by means of the patient inputdevice 18 and the network 2 in step 616. The patient may ceaseimplementing the prescriptive behaviors in step 618. Alternatively, thepatient may determine to proceed from step 614 to step 620 and to querythe PMDS 10 to determine whether the prescription assigned by the PMDS10 has been modified. When the patient determines in step 620 that theassigned prescription has not been modified, the patient proceeds fromstep 620 back to step 608. When the patient determines in step 620 thatthe assigned prescription has been modified, the patient proceeds fromstep 620 back to step 602 to receive and review the modified assignedprescription.

Referring now generally to the Figures and particularly to FIG. 7, FIG.7 describes a process implemented by the PMDS 10 in communication withthe network 2, the sensors 20, 22, 23 and 24 and the IEMD 4. In step702, the PMDS 10 receives a marker datum IEM M of an ingestion reporttransmitted from the IEMD 4. In step 704, the PMDS 10 compares themedicine identified by the marker datum IEM M and the time of receipt ofthe marker datum IEM M with the medication records R.0.MR.0-R.0.MR.N.The PMDS 10 determines in step 7.06 whether the marker datum IEM Mreceived step 7.02 is compliant with a medication recordR.0.MR.0-R.0.MR.N. When the PMDS 10 determines in step 7.06 that receiptof the marker datum IEM M of step 7.02 is noncompliant with a medicationrecord R.0.MR.0-R.0.MR.N, the PMDS 10 records the instant receipt of themarker datum IEM M in the patient history data H.D as a noncompliantevent and issues and transmits a patient notice of nonadherence in step710 to the patient transceiver 8 and/or the patient input device 18.When the PMDS 10 determines in step 7.06 that receipt of the markerdatum IEM M of step 7.02 is compliant with a medication recordR.0.MR.0-R.0.MR.N, the PMDS 10 updates patient history data H.D in step712 with a notation of adherence. The PMDS 10 proceeds from either step710 or 712 to step 714 and to perform alternate computationaloperations.

Referring now generally to the Figures and particularly to FIG. 8, FIG.8 is a process chart of a method in which a clinician or an expertsystem monitors a vital parameter of the patient and suggest via thenetwork 2 a therapeutic behavior intended to improve the health of thepatient. In step 802 the PMDS 10 receives vital parameter data from oneor more sensors 20, 22, 23 and 24. In step 804 the PMDS 10 compares thevital parameter data received in step 802 with a range of healthy valuesof the instant vital parameter, for example, heart rate, blood pressure,respiration rate, respiration intensity, and electrical skinconductivity. The PMDS 10 determines in step 806 whether the vital datareceived in step 802 falls within the healthy range of the instant vitalparameter as stored in the PMDS 10 or elsewhere in the network 2. Whenthe PMDS 10 determines in step 806 that the vital data received in step802 does not falls within the healthy range of the instant vitalparameter, the PMDS 10 proceeds from step 806 to step 808 and correlatesthe time of the receipt of the vital parameter data with the activityschedule of patient activity data R.ACT of one or more patient recordsR.0-R.N associated with the patient. In step 810 the PMDS 10 selects atherapeutic behavior intended to encourage the patient to maintain thevital parameter referenced in step 802 within the healthy range selectedin step 802. The therapeutic behavior selected in step 810 may beprovided by a clinician by input to the PMDS 10 or by means of thepatient-messaging module 14. When the vital parameter referenced in step802 is hypertension of the cardiovascular system, the selectedtherapeutic behavior may be or include, for example, listening tocalming music, performing meditation, and/or physical exercise. In step812 the therapeutic behavior is prescribed to the patient in view of apatient activity associated in the patient activity data R.ACT with thetime of the receipt of the vital parameter data received in step 802. Apatient behavior suggestion is transmitted from the PMDS 10 and/or thepatient messaging module 14 in step 814, wherein the suggestion advisesthe patient to engage in the therapeutic behaviors selected in step 810at times correlated with patient behavior correlated in step 808 andreported in the patient activity data R.ACT. The PMDS 10 proceeds fromstep 816 and to perform alternate or additional computationaloperations.

Referring now generally to the Figures and particularly to FIG. 9, FIG.9 is a process chart of a method of the PMDS 10 to determine if and whento send a text or audio message to the patient transceiver 8 and/or thepatient input device 18. In step 902 the PMDS accesses one or morepatient records R.0-R.N. The PMDS 10 determines in step 904 whether aningestion of a medicine has been prescribed to the patient. When thePMDS determines in step 904 that the patient has not been prescribed toingest a medication, the PMDS 10 proceeds on from step 904 to step 906and to perform alternate or additional computational operations.

When the PMDS determines in step 904 that the patient has beenprescribed in a medication record R.0.MR.0-R.0.MR.N of a patient recordR.0-R.N to ingest an IEMD 4 containing a medication, the PMDS 10proceeds on from step 904 to step 908, and to examine the first remindflag FLAG1 of the instant medication record R.0.MR.0-R.0.MR.N. When thefirst remind flag FLAG1 indicates an instruction to remind the patientof a recommended medication ingestions. When the first remind flag FLAG1indicates an instruction to remind the patient of prescribed medicineingestion recommendations, the PMDS 10 proceeds from step 908 to step910. The PMDS 10 calculates the next scheduled time for an IEMD 4ingestion in step 910 by analyzing information of the applicationschedule MED.S and calculates the next scheduled ingestion time TNEXT.The PMDS 10 reads the first remind time period TR1 from the medicationrecord R.0.MR.0-R.0.MR.N accessed in step 908. The PMDS 10 accesses thereal time clock 27 determines the current real time TACTUAL in step 914,and calculates the time difference TDELTA between the current timeTACTUAL and the next scheduled ingestion time TNEXT. The PMDS 10determines in step 918 whether the time difference TDELTA is less thanthe first remind time period TR1. When the PMDS 10 determines in step918 that the time difference TDELTA is not less than the first remindtime period TR1, the PMDS 10 proceeds from step 918 to step 906. Whenthe PMDS 10 determines in step 918 that the time difference TDELTA isless than the first remind time period TR1, the PMDS 10 proceeds fromstep 918 to step 920 and selects the first remind text TXT1 from themedication record R.0.MR.0-R.0.MR.N accessed in step 908, and transmitsthe first remind text TXT1 to the patient transceiver 8 and/or thepatient input device 18 in step 922.

The PMDS 10 proceeds from either step 922 or step 906 to step 924 and todetermine whether to cease monitoring for transmissions of markers IEM Mfrom the IEMD 4 and the sensors 20, 22, 23 and 24. When the PMDS 10determines to continue monitoring the sensors 20, 22, 23 and 24 and fortransmissions of markers IEM M from the IEMD 4, the PMDS 10 proceedsfrom step 924 to step 902. When the PMDS 10 determines to ceasemonitoring the sensors 20, 22, 23 and 24 and for transmissions ofmarkers IEM M from the IEMD 4, the PMDS 10 proceeds from step 924 tostep 926 perform alternate or additional computational operations.

Referring now generally to the Figures and particularly to FIG. 10, FIG.10 is a process chart of a method of the PMDS 10 to determine if andwhen to send a text or audio message to the patient transceiver 8 and/orthe patient input device 18 when an ingestion marker datum IEM M is notreceived approximately when a marker datum IEM M would be received whenthe IEMD 4 is ingested prescribed. In step 1002 the PMDS accesses one ormore patient records R.0-R.N. The PMDS 10 determines in step 1004whether an ingestion of a medicine has been prescribed to the patient.When the PMDS determines in step 1004 that the patient has not beenprescribed to ingest a medication, the PMDS 10 proceeds on from step1004 to step 1006 and to perform alternate or additional computationaloperations.

When the PMDS determines in step 1004 that the patient has beenprescribed in a medication record R.0.MR.0-R.0.MR.N of a patient recordR.0-R.N to ingest an IEMD 4 containing a medication, the PMDS 10proceeds on from step 1004 to step 1008, and to examine the secondremind flag FLAG2 of the instant medication record R.0.MR.0-R.0.MR.N.When the second remind flag FLAG2 indicates an instruction to remind thepatient of a recommended medication ingestion when an ingestible eventmarker datum IEM M has not been received as would be when an IEMD 4 hadbeen ingested as directed by the medication record R.0.MR.0-R.0.MR.N ofstep 1004. When the second remind flag FLAG2 indicates an instruction toremind the patient of a tardiness in following prescribed medicineingestion as prescribed, the PMDS 10 proceeds from step 1008 to step1010. The PMDS 10 calculates the next scheduled time for an IEMD 4ingestion in step 1010 by analyzing information of the applicationschedule MED.S and calculates the next scheduled ingestion time TNEXT.The PMDS 10 accesses the real time clock 27 determines the current realtime TACTUAL in step 1012, and calculates the time difference TOVERbetween the current time TACTUAL and the scheduled ingestion time TNEXTIN STEP 1014.

The PMDS 10 reads the second remind time period TR2 in step 1016 fromthe medication record R.0.MR.0-R.0.MR.N accessed in step 1008. The PMDS10 determines in step 1018 whether the time difference TOVER calculatedin step 1014 is less than the second remind time TR2 of step 1016. Whenthe PMDS 10 determines in step 1018 that the time difference TOVER isless than the second remind time TR2, the PMDS 10 proceeds from step1018 to step 1006. When the PMDS 10 determines in step 1018 that thetime difference TDELTA is not less than the second remind time TR2, thePMDS 10 proceeds from step 1018 to step 1020 and selects the secondremind text TXT2 from the medication record R.0.MR.0-R.0.MR.N accessedin step 1008, and transmits the second remind text TXT2 to the patienttransceiver 8 and/or the patient input device 18 in step 1022.

The PMDS 10 proceeds from either step 1022 or step 1006 to step 1024 andto determine whether to cease monitoring for transmissions of markers Mfrom the IEMD 4 and the sensors 20, 22, 23 and 24. When the PMDS 10determines to continue monitoring the sensors 20, 22, 23 and 24 and fortransmissions of markers M from the IEMD 4, the PMDS 10 proceeds fromstep 1024 to step 1002. When the PMDS 10 determines to cease monitoringthe sensors 20, 22, 23 and 24 and for transmissions of markers M fromthe IEMD 4, the PMDS 10 proceeds from step 1024 to step 1026 performalternate or additional computational operations.

Referring now generally to the Figures and particularly to FIGS. 2, 4A,4B, 4C, and 4D, the audio/text converter module 64 is configured toconvert digitized audio data received from the patient transceiver 8,the patient input device 18, the patient messaging module 14, the firstnetwork transceiver 12 and/or the second network transceiver 16 intotextual data for storage in a patient record R.0, for example in thepatient history data H.D, the patient activity data R.ACT, the firstremind text TXT1, the second remind text TXT2, the first behavior remindtext TXT1B and the second behavior remind text TXT2B, and/or thebehavior description text BHR.D.

The audio/text converter module 64 is further configured to convert textdata into digitized audio data representative of vocalizations of thesource text data from the PMDS 10 and/or the patient messaging module 14and for transmission of the digitized audio data representations to thepatient transceiver 8 and/or the patient input module 18. The text dataand the digitized audio data may be received via the bus 34 and from thesystem memory 28 or the network 102, or generated by the CPU 26.

Referring now generally to the Figures and particularly to FIG. 12, FIG.12 is a schematic of a patient coupled with a plurality of biometricsensors and in communication with a cellular telephone, other mobilecomputational devices and information technology networks. In oneexample, it is a schematic of a patient 88 with a blood pressure sensor90 wrapped around a right arm 92, a wireless heart rate sensor 94 incontact with a right leg 96, a wireless body temperature sensor 98positioned within a left ear canal 100, and a respiration monitor 102positioned at a patient's mouth and nose area 104. These sensors arebi-directionally communicatively coupled to a first network computer106. To illustrate, biometric data may include body related data, e.g.,temperature, ph factor, pulse rate, and ingestion data may include eventand/or medication related data, e.g., nature, type of medication,dosage, time at which ingestion took place, adherence to prescription,level of adherence to prescription, etc., communicated to a wirelesscommunications device or receiver, e.g., computer, patch receiver, etc.The biometric data may include, for example, a unique identifier whichmay be compared to various data, e.g., genetic profile data, emotionaldata, and other data. Such data may be associated with one or more of avariety of devices, e.g., cellular phone, wireless computer, PDA, andwireless comms system or receiver for validation purposes.

A database computer 108, or “DB computer” 108, and a medical diagnosticcomputational system 110 (hereinafter, “diagnostic system” 110) arebi-directionally communicatively coupled with the network 2. Asoftware-encoded database may be associated with the database computer108 and may include current and historical data pertaining to thepatient 88. The historical data includes, for example, medicalrecord(s), health record(s), or medical chart(s) which are systematicdocumentation of a patient's medical history and care. The term “medicalrecord” is used both for the physical information for the patient andfor the body of information which comprises the total of each patient'shealth history. The network 2 is bi-directionally and communicativelycoupled with a telephonic network, represented by telephony network 2Aand with other forms of telecommunication devices, e.g., fax etc,represented by, telecommunications network 112 (hereinafter “TELCO”112).

Communication devices, for example, a digital cellular telephone 114, awireless enabled network computer 116 and a wireless enabled personaldigital assistant (PDA) 118 are further bi-directionally communicativelycoupled with the network 2 via a wireless communications system 120(hereinafter “wireless comms system” 120). It is understood that thedefinition of the term “computer” as used in the present disclosuresincludes, for example, digital cellular telephones, personal digitalassistants, network computer, computer workstations, automated databasesystems, servers, and web servers.

In another aspect, one or more sensors 20, 22, 23, 24, 94, 98, and/or102 may be conductively or communicatively coupled to a patch receiver122, positioned on the skin or subcutaneously or as a wristband or anysuch wearable device. The patch receiver 122 in turn may becommunicatively coupled to the first network computer 106. The firstnetwork computer 106 is bi-directionally communicatively coupled toelectronics communications network 2. The network 2 may furtherfacilitate a two-way communication with the Internet 2B.

An IEMD 4 optionally includes a medicine 126. The IEMD 4 is an in-bodydevice as disclosed herein. Examples of in-body devices include, but arenot limited to: implantable devices, e.g., implantable therapeuticdevices, such as but not limited to stents, drug delivery devices,orthopedic implants, implantable diagnostic devices, e.g., sensors,biomarker recorders, etc.; ingestible devices such as the IEMD 4described in the preceding references; etc.

In various aspects, the biometric data may be communicated to and/orfrom one or more receiving devices (not shown), for example, a biometricdata receiver such as the computer 106, etc. The biometric receiver 106,114, 116, 118 and 120 may be embodied in various ways, for example, asthe cellular telephone 114, the wireless computer 116, the personaldigital assistant 118, and/or a personal receiver such as an implantablereceiver, a semi-implantable receiver, and an externally applied devicesuch as the personal signal patch receiver 122. The patch receiver is apersonal receiver that may be removably affixed to the person's person,apparel, or personal equipment, for example, by an adhesive, a clip, afabric, or other suitable attachment means known in the art.

To illustrate one exemplary application of the method of the presentinvention, a patient 88 may ingest the IEMD 4 integrated with medicine126. The IEMD 4 may communicate data that includes biometric data andingestion data. The biometric data may include body related data, forexample, temperature, pH factor, pulse rate, and ingestion data mayinclude event and/or medication related data, for example, nature, typeof medication, dosage, time at which ingestion took place, adherence toprescription, level of adherence to prescription, etc., communicated toa wireless communications device 114, 116, 118, and 120, or receiver,for example, computer 106, patch receiver, etc. The biometric data mayinclude, for example, a unique identifier which may be compared tovarious data, for example, genetic profile data, emotional data, andother data. Such data may be associated with one or more of a variety ofdevices, for example, the cellular phone 114, the wireless computer 116,PDA 118, and the wireless comms system 120 or receiver for validationpurposes,

The biometric data reception may be affected or effected by one or morereceiving devices, for example, personal signal receivers such as patchreceivers that are removably attachable externally to the patient 88 ora non-human body; or comprised within a subcutaneous device, animplantable devices, and/or various external devices, for example,devices which are or are not designed for attachment or other permanentor semi-permanent contact with the body, for example, the cellulartelephone 114. An ingestible event marker system is described in thePatent Application PCT/US2008/52845 and includes an IEMD 4 and apersonal patch signal receiver 122. The patch receiver 122 includes, forexample, devices capable of at least receiving data and/or signals, etc.Patch receivers 122 may be attachable, for example, permanently orremovably attachable externally to a human body or a non-human body. Forexample, the patch receiver 122 may include the receiver and an adhesivelayer to provide for attachment to and removal from the patient 88.Alternatively, the patch receiver 122 may be implantable orsemi-implantable, for example, subcutaneous implantation.

The wireless communications system 120, the cellular telephone 114, thewireless computer 116, and/or the personal digital assistant 118, mayinclude systems, subsystems, devices, and/or components that receive,transmit, and/or relay the biometric data. In various aspects, thewireless communications system 120 communicably interoperates with areceiver 37 such as the patch receiver 120 and a communications network2 such as the Internet 2B. Examples of wireless comms systems 120 arecomputers, for example, servers, personal computers, desktop computers,laptop computers, intelligent devices/appliances, etc., as heretoforediscussed.

In various aspects, the wireless communications system 120 may beembodied as an integrated unit or as distributed components, forexample, a desktop computer and a mobile telephone in communication withone another and in communication with a patch receiver and the Internet2B.

Further, various aspects of the network include combinations of devices.For example, one such combination is a receiver 122 such as the patchreceiver 122 in communication with the portable digital assistant 118 orthe mobile telephone 114. Thus, for example, the patch receiver 122wirelessly transmits biometric data received from the IEMD 4 to thecellular telephone 114 having a receiver and a software agent availablethereon. The cellular telephone 114 receives the biometric datatransmitted by the IEMD 4. In one scenario, the patient 88 ingestsprescription medication 126 in conjunction with an IEMD 4. The IEMD 4identifies various information, for example, the medication type anddosage and transmits this information in a biometric data transmissionvia, for example, a conductive transmission to the patch receiver 120,which may be removably attached to the patient 88. The patch receiver122 transmits the biometric data to, for example, the cellular telephone114, the wireless computer 116, the personal digital assistant 118,and/or the wireless comms device 120 as the case may be.

For ease of description, the in-body devices of the invention will nowbe further described in terms of configurations having current pathextender capabilities such as those provided by a skirt (not shown)where the skirt is part of the IEMD 4, for example, the wireless IEMD 4.One or more IEMD 4 may be or comprise a composition that includes incertain configurations a vehicle, where the vehicle may or may notinclude an active agent such as the medicine 126.

IEMDs 4 of interest include those described in PCT Application No.PCT/US2006/016370 filed on Apr. 28, 2006 titled “Pharma-InformaticsSystem”; PCT Application No. PCT/US2007/022257 filed on Oct. 17, 2007titled “In-vivo Low Voltage Oscillator for Medical Devices”; PCTApplication No. PCT/US2007/82563 filed on Oct. 25, 2007 titled“Controlled Activation Ingestible Identifier”; U.S. patent applicationSer. No. 11/776,480 filed Jul. 11, 2007 titled “Acoustic PharmaInformatics System”; PCT/US2008/52845 filed on Feb. 1, 2008 titled“Ingestible Event Marker Systems”; Patent Application No. PCT/US08/53999filed Feb. 14, 2008 titled “In-Body Power Source Having High SurfaceArea Electrode”; U.S. patent application Ser. No. 12/238345 filed Sep.25, 2008 titled “In-Body Device With Virtual Dipole SignalAmplification”, the disclosures of which applications are hereinincorporated by reference.

The IEMD 4 communicates, e.g., generates, alters, produces, emits, etc.,a communication upon contact of the IEMD 4 with a target physiologicallocation (or locations) depending on the particular configuration of theIEMD 4. The IEMD 4 of the present compositions may vary depending on theparticular configuration and intended application of the composition.

As such, variations of IEMDs 4 may communicate, for example, communicatea unique identifier, when activated at a target site, for example, whenthe instant IEMD 4 contacts a target surface or area within thepatient's body 6, for example, a physiological, site and/or alters acurrent when in contact with a conducting fluid, for example, gastricacid in the stomach. Depending on the configuration, the targetphysiological site or location may vary, where representative targetphysiological sites of interest include, for example, but are notlimited to: a location in the alimentary system, such as the mouth,esophagus, stomach, small intestine, large intestine, etc.

In certain configurations, the IEMD 4 is configured to be activated uponcontact with fluid at the target site, for example, stomach fluid,regardless of the particular composition of the target site. In someconfigurations, the IEMD 4 is configured to be activated byinterrogation, following contact of the composition with a targetphysiological site. In some configurations, the IEMD 4 is configured tobe activated at a target site, wherein the target site is reached aftera specified period of time.

Depending on the needs of a particular application, the communication ofan ingestible event marker datum IEM M associated with the event markerIEMD 4, for example, altered current, an RFID signal, etc., may begeneric such as a communication that merely identifies that thecomposition has contacted the target site, or may be unique, forexample, a communication which in some way uniquely identifies that aparticular event marker datum TEM M from a group or plurality ofdifferent markers M in a batch has contacted a target physiologicalsite.

As such, the IEMD 4 may be one that, when employed with a batch of unitdosages, for example, a batch of tablets, is associated with acommunication which cannot be distinguished from the signal emitted bythe IEMD 4 of any other unit dosage member of the batch. In yet otherconfigurations, each member of the batch has an IEMD 4 that isassociated with a unique communication, at least with respect to all theother ingestible event markers of the members of the batch. For example,each wireless ingestible device IEMD 4 of the batch emits a signal thatuniquely identifies that particular wireless ingestible device in thebatch, at least relative to all the other ingestible event markers M ofthe batch and/or relative to a universe of ingestible event markers M.In one configuration, the communication may either directly conveyinformation about a given event, or provide an identifying code, whichmay be used to retrieve information about the event from a database, forexample, a database linking identifying codes with compositions.

The IEMD 4 may generate a variety of different types of signals as amarker datum IEM M, including, for example, but not limited to: RFsignals, magnetic signals, conductive (near field) signals, acousticsignals, etc. Of interest in certain configurations are the specificsignals described in the PCT application serial no. PCT/US2006/16370filed on Apr. 28, 2006; the disclosures of various types of signals inthis application being specifically incorporated herein by reference.The transmission time of the IEMD 4 may vary, where in certainconfigurations the transmission time may range from about 0.1microsecond to about 48 hours or longer, for example, from about 0.1microsecond to about 24 hours or longer, for example from about 0.1microsecond to about 4 hours or longer, for example from about 1 sec toabout 4 hours, including from about 1 minute to about 10 minutes.Depending on the given configuration, the IEMD 4 may transmit a givensignal once. Alternatively, the IEMD 4 may be configured to transmit asignal with the same information, for example, identical signals, two ormore times, where the collection of discrete identical signals may becollectively referred to as a redundant signal.

Various configurations of elements are possible, e.g., dissimilarmaterials 124A, 124B. When in contact with a conducting fluid, a currentis generated. A control device 124C may alter the current. The alteredcurrent may be detectable, for example, by a receiving device, etc., andassociated with a communication providing a unique IEM, etc., aspreviously discussed. The dissimilar materials making up the electrodescan be made of any two materials appropriate to the environment in whichthe identifier will be operating. The dissimilar materials are any pairof materials with different electrochemical potentials. For example, insome configurations where the ionic solution comprises stomach acids,electrodes may be made of a noble metal, e.g., gold, silver, platinum,palladium or the like, so that they do not corrode prematurely.Alternatively, for example, the electrodes can be fabricated of aluminumor any other conductive material whose survival time in the applicableionic solution is long enough to allow the identifier to perform itsintended function. Suitable materials are not restricted to metals, andin certain configurations the paired materials are chosen from metalsand non-metals, for example, a pair made up of a metal (such as Mg) anda salt. With respect to the active electrode materials, any pairing ofsubstances, for example, metals, salts, or intercalation compounds, thathave suitably different electrochemical potentials (voltage) and lowinterfacial resistance are suitable.

Various other configurations may include other communication-relatedcomponents, for example, an RFID signal generator, etc.

In various aspects, the IEMD 4 communicates an ingestion alert when themedicine 126 is dissolved within a gastrointestinal pathway of thepatient 88. The IEMD 4 is configured to transmit the ingestion alert asa wireless transmission that is detectable by, for example, the cellulartelephone 114, the wireless enabled network computer 116, the wirelessenabled personal digital assistant 118, and/or the wireless comms system120. In addition, the wireless heart rate sensor 94, the wireless bodytemperature sensor 98, and/or the respiration monitor 16 are optionallyconfigured to transmit biometric measurements in a wireless transmissionthat is detectable by, for example, the cellular telephone 114, thewireless enabled network computer 116, the wireless enabled personaldigital assistant 118 and/or the wireless comms system 120. The wirelesstransmissions, for example, of the IEMD 4, the wireless heart ratesensor 94, the wireless body temperature sensor 98, and/or therespiration monitor 102 alternately or additionally are or compriseradio frequency wave or pulse transmissions and/or light wave or pulsetransmissions.

Information regarding alternate configurations of the pharmaceuticalcomposition 40 and the IEMD 4 are disclosed in U.S. Patent ApplicationPublication No. 20080284599, published on Nov. 20, 2008 titled“Pharma-Informatics System”, which is incorporated by reference in itsentirety and for all purposes in this document.

Referring now generally to the Figures and particularly to FIG. 13, FIG.13 is an illustration of a display screen 128 of the cellular telephone114, the wireless enabled network computer 116 and/or the wirelessenabled personal digital assistant 118 wherein a plurality of icons129-136 are available for user selection. In one configuration, thedisplay screen 128 is a touch screen and the icons 129-136 are selectedby the application of the patient 88 of finger pressure or body heat. Inother configurations, alternately or additionally the patient 88 mayselect one or more icon by positioning a cursor 138 over an icon 129-136and selecting the icon 129-136 over which the cursor 138 is positionedby means of an input device 140 of, for example, the cellular telephone114, the wireless enabled network computer 116 and/or the wirelessenabled personal digital assistant 118. The medicine cursor 138 isselected by the patient 88 to indicate a taking of the medicine 126, forexample by an oral or nasal ingestion of one or more pharmaceuticalcompositions 122, a topical application of the medicine 126, orinjection or other introduction of the medicine 126 to the patient 88.Accomplishment icon 130 is selected by the patient 88 to indicate anachievement or an engagement in an activity, for example an athleticsession, exercise or event, a hobby, a meditation session, a therapeuticpractice or exercise, a leisure activity, a recreational activity, arehabilitative activity, a period of sleep, a meal consumption, a liquidingestion, an erotic thought, erotic act, or an occurrence of an aspectof menstruation.

Each emotion icon 129-136 is selected by the patient 88 to indicate aperception of an associated emotion or a psychological state by theuser, for example an emotion or psychological state of happiness,appreciation, kindness, love, joy, fondness, bliss, anger, fear, dread,loathing, anxiety, jealousy, envy, contempt, resentment, perceived pain,perceived pleasure, confidence, insecurity, optimism, pessimism,patience, impatience, attraction, repulsion, clarity, confusion,encouragement, discouragement, a romantic sensation, a sexual arousal,or an erotic sensation. Each sad icon 134-135 is selected by the patient88 to report an occurrence of an undesirable event or condition, forexample nausea, diarrhea, anxiety, physical pain, bleeding, or a loss ofbalance. An external icon 136 may be selected by the patient 88 toindicate a perception of an event or condition external to the patient88, for example an inbound phone call or a visit from a friend. It isunderstood that each icon 129-136 may be individually associated with asingle emotion, perception, event, process or condition.

Referring now generally to the Figures and particularly to FIG. 14, FIG.14 is a schematic diagram of the cellular telephone 114. It isunderstood that the network computer 106, the wireless enabled networkcomputer 116, the wireless enabled personal digital assistant 118 andthe wireless comms system 120 may comprise one or all of the elements ofthe cellular telephone 114.

The cellular telephone 114 includes a central processing unit 142, or“CPU” 142 and a firmware 144. The firmware 144 further includes a set ofsoftware-encoded instructions comprising a mobile basic input outputsystem 146 used to boot-up the cellular telephone 114. A power andcommunications bus 148 (or “mobile bus” 148) bi-directionallycommunicatively couples the CPU 142, the firmware 144, a display deviceinterface 150, the input device 140, a telephone audio output module152, a wireless network interface 154, a global positioning systemmodule 156, a telephone system memory 158, a telephone mediawriter/reader 160, a date time circuit stamp 162, a telephone audioinput module 164, a telephone mechanical vibration module 166, a smallmessage service module 168, and an accelerometer 170.

The display interface 150 bi-directionally communicatively couples adisplay module 172 comprising a telephone display screen 174 with thecommunications bus 148. The telephone audio output module 152 acceptsdigitized information from the bus 148 and derives and generates anaudible sound wave output therefrom.

An electrical power battery 176 provides energy to the elements 142-174of the cellular telephone 114 via the mobile bus 148.

The wireless network interface 154 bi-directionally communicativelycouples the electronics communications bus 146 and the network 2. Thesystem memory 158 is a random only access memory wherein a mobiletelephone system software 178 is maintained and optionally edited ormodified by deletion, addition or update of software-encodedinstructions.

The global positioning system module GPS (hereinafter “GPS module” 156)is a communications device that communicates with a global positioningsystem that comprises earth-orbiting satellites and allows the GPSmodule 156 to determine coordinates of the location of the GPS module156 on the earth's surface.

The date/time circuit 162 is bi-directionally communicatively coupledwith the communications bus 148 and provides a digitized date time stampdata when polled by the telephone CPU 142. The date/time circuit 162further generates time pulses and synchronizing signals that thetelephone CPU 142 and the cellular telephone 114 generally, apply tomeasure the passage of time, time period durations, and to schedulealarms and alerts.

The telephone media writer/reader 160 is configured to read, andoptionally write, machine readable, computer executable software encodedinstructions from a computer program product 180. The telephone mediawriter/reader 160 and the associated computer program product 180 areselected and configured to provide non-volatile storage for the cellulartelephone 114. Although the description of computer program product 180contained herein refers to a mass storage device, for example a harddisk or CD-ROM drive, it should be appreciated by those skilled in theart that computer program product 160 can be any available media thatcan be accessed by the digital telephone 114.

By way of example, and not limitation, computer program product 180 maybe or comprise computer operable storage medium 182 and communicationmedia. Computer operable storage media 182 include, for example,volatile and non-volatile, removable and non-removable media implementedin any method or technology for storage of information such ascomputer-readable instructions, data structures, program modules orother data. Computer operable storage media include, for example, butare not limited to, RAM, ROM, EPROM, EEPROM, flash memory or other solidstate memory technology, CD-ROM, digital versatile disks (“DVD”), orother optical storage, magnetic cassettes, magnetic tape, magnetic diskstorage or other magnetic storage devices, or any other medium which canbe used to store the desired information and which can be accessed bythe cellular telephone 144.

The computer program product 180 may comprise machine-readableinstructions within a computer operable storage medium which whenexecuted by the computer to cause the computer to perform one or moresteps as described in the Figures and enabled by the present disclosure,and/or generate, update, maintain and apply one or more data structures.

The input device 140 may be or comprise a character input keypad 184and/or a mouse 186, or other point and click selection or data inputdevice known in the art.

Referring now generally to the Figures and particularly to FIG. 15, FIG.15 is a schematic diagram of the mobile telephone system software 178 ofthe cellular telephone 114. A mobile device operating system 188 acts asa control layer between the hardware elements 142-186 of the cellulartelephone 114 and the mobile system software 178 of the cellulartelephone 114. A network communications software 190 enables thewireless network interface 154 to bi-directionally couple the network 2with internal communications bus 148 and the CPU 142. A mobile displaydevice driver 192 enables the CPU 142 to direct the state of thetelephone display screen 128 to include the rendering of the icons129-136. A mobile input device driver 194 enables the CPU 142 to accept,execute and interpret commands, instructions, data and selections fromthe input device 140. A mobile reader driver 196 enables the CPU 140 toaccept, execute and interpret software encoded programs, commands,instructions, data and selections from the computer program product 180.A graphical user interface driver 198, or “mobile GUI” 198, enables thecellular telephone 114 to visually render data, for example, to renderthe icons 129-136.

The mobile telephone system software 178 further includes a data basemanagement system 98 (hereinafter, “mobile DBMS” 200) storing aplurality of records 202.A-202.N. and a plurality of logged event data204.A-204.N (hereinafter, “log” 204.A-205.N). The system software 178further comprises a plurality of software applications 206.A-206.N.

Referring now generally to the Figures and particularly to FIG. 16, FIG.16 illustrates a first aspect of a method wherein an exemplary processis represented. In the process of FIG. 16, the cellular telephone 114powers up in step 1600 and displays one or more icons 129-136 in step1602. The computer determines in step 1604 whether the patient 88 hasselected an icon 129-136. When the cellular telephone 114 determines instep 1604 that the patient 88 has selected an icon 129-136, the cellulartelephone 114 proceeds on to step 1606 to form an exemplary record 202.Aand store the record 202.A in the DBMS 188, wherein the record 202.Aincludes an icon identifier and a date/time stamp data generated by thedate time circuit 162 and related to the time of selection of the icon129-136.

The cellular telephone 114 determines in step 1608 whether or not todisplay the information contained or associated with the exemplaryrecord 202.A in a graphical representation on the display screen 128.The cellular telephone 114 renders information of the record 202.A in avisually presented temporal relationship with information containedwithin or associated with the plurality of logged event data204.A-204.N. The cellular telephone 114 alternately displays thegraphical representation, such as an exemplary graph 181 of FIG. 18, instep 1610, or proceeds on to step 1612. The cellular telephone 114determines in step 1612 to return or continue to display the icons129-136 in step 1602, or to proceed on to step 1614 and cease displayingthe icons 129-136 in step 1612 and to continue on to perform alternatecomputational processes.

Referring now generally to the Figures and particularly to FIGS. 17A and17B, FIG. 17A is an illustration of the exemplary record 202.A thatincludes an icon identifier 202.A.1. The date time stamp 202.A.2 isgenerated by the date time circuit 162. The icon identifier 202.A.1associates the exemplary record 202.A with an icon 29-36. FIG. 17B is anillustration of the exemplary log event data 204.A that includes abiometric identifier 204.A.1, a measured biometric value 204.A.2 and anevent date time stamp 204.A.3 related to the time of recordation of theevent biometric value 204.A.2. In certain exemplary methods, thebiometric identifier 204.A.1 may associate the exemplary log data 204.A.with a measurement, for example, of a heart rate, a blood pressure, abody temperature, and/or a respiration, wherein the measured biometricvalue 204.A.2 may be a numeric value of the biometric parameteridentified by the biometric identifier 204.A.1 of the exemplary log data204.A. An optional record information 202.A.3 includes additionalinformation provided by the patient 88 via the input module 140, byuploading from a computer program product 180 and/or by downloading fromthe network 2. The record information 202.A.3 may include textualinformation entered from a computer keyboard 184 or mouse 186. Accordingto even other additional or alternate methods, the record information202.A.3 may optionally be input to the cellular telephone 114 via anaudio input module 164 that accepts sound waves and generates digitizedrecordings therefrom, wherein the digitized recordings may be stored asaudio data in the record information 202.A.3. In addition, the audioinput and/or a textual interpretation of sound waves received by theaudio input module 122 and thereupon stored as text data in the recordinformation 202.A.1.

When the icon identifier 202.A.1 indicates that the identified icon132-136 specifies an accomplishment, or the record information 202.A.3indicates that that the comprising exemplary record 202.A identifies anaccomplishment, the exemplary record 202.A is defined as anaccomplishment record 202.A, and the exemplary record information202.A.3 is defined as an accomplishment information 202.A.3.

Referring now generally to the Figures and particularly to FIG. 18, FIG.18 illustrates a graph 206 wherein a plurality of event log data204.A-204.N that each datum includes a beats per minute measurementvalue as the biometric value 204.A.2-204.N.2. Each biometric value204.A.2-204.N.2 is plotted within the graph 206 according to its valuealong a heart rate axis 208.A and the value of the date time stamp204.A.3-204.N.3 of the same event log data 204.A-204.N along a time axis208.B. In addition, one or more records 202.A-202.N are plotted asevents along the same time axis 208.B, wherein the quality associatedwith each displayed record 202.A-202-N is presented along the time axis208.B. The patient 88 may thus review the graph 206 and observe thetemporal relationship between each event documented by a record202.A-202.N and the biometric data measurement values 204.A.2-204.N.2contained in the plurality of event log data 204.A-204.N.

Referring now generally to the Figures and particularly to FIG. 19, FIG.19 is an illustration of an additional or alternate method, wherein thecellular telephone 114 transmits in step 1902 the exemplary record 202.Avia the network 2 to the data base system 108 and/or the diagnosticsystem 110. In step 1904 the cellular telephone 114 receives a digitizedmessage that includes a medical advice content via the network 2. Thecellular telephone 114 displays the medical guidance content in thedisplay screen 128 in step 1906. In a yet other aspect of the method ofthe FIG. 19, the medical guidance content is rendered as an audiblesignal output through the audio output module 152.

Referring now generally to the Figures and particularly to FIG. 20, FIG.20 is an illustration of a still additional or alternate aspect of themethod of the of FIG. 20 wherein the cellular telephone 114 receives oneor more event logs 204.A-204.N in step 2002 via the network 2. Thecellular telephone 114 then stores the one or more event logs204.A-204.N in the mobile DBMS 200 in step 2004. The one or more eventlogs 204.A-204.N received in step 2002 will then be included in the nextcalculation of the graph 206 in the next execution of step 1610. It isunderstood that the one or more event logs 204.A-204.N received in step2002 may include biometric measurement values 204.A.2-204.N.2 that aremeasures, for example, of heart rate, blood pressure, respiration orbody temperature.

Referring now generally to the Figures and particularly to FIGS. 3 and21, FIG. 21 illustrates a still other additional or alternate method,wherein GPS data collected from the cellular telephone 114 of thepatient 88 are used to determine the current and relative level ofsocial interaction in which the patient 88 is engaging. In step 2102 thecellular telephone 114 is associated with the patient 88. In step 2104the communications traffic of the cellular telephone 114 is monitoredand each phone call is recorded in a session record 210.A-210.N of thepatient database 40 of the PMDS 10. The monitoring of the use of thecellular phone 114 may be accomplished by a telecommunications carrierfrom whom the patient 88 receives a communications enabling serviceand/or by monitoring by the wireless comms system 120. The sessionrecords 210.A-210.N and the patient database are transmitted to, storedin, and made accessible for review to a diagnostician at the diagnosticsystem 110 and/or the data base computer 108 in step 2106. Thediagnostician determines in step 2108 that the level of socialinteraction indicates an increased risk of degradation in the state ofmental health of the patient 88, the diagnostician then determines instep 2110 whether or not to issue an alarm to alert the patient 88 orthird parties of a potential decline in mental health. An alarm istransmitted to and rendered in step 2112 by the cellular telephone 114in optional step 1012. Additionally or alternatively, the diagnosticianmay in step 2114 generate a therapeutic recommendation, e.g., adiagnosis of, study of, analysis of, determination of or a prescriptionregarding, one or more health issues of the patient 88 in step 2114, andoptionally the medical advice generated in step 2114 is transmitted toand rendered by the cellular telephone 114 in step 2116. It isunderstood that either or both the alarm transmitted and rendered instep 2112 and the advice transmitted and rendered in step 2116 mayoptionally, alternatively or additionally be sent to and rendered by thecellular telephone 114, the first network computer 106, thewireless-communications enabled network computer 116 and/or thewireless-communication enabled personal digital assistant 118 in wholeor in part.

Referring to FIGS. 14, 15 and 21, it is understood that the cellulartelephone 114 may have a plurality of pre-recorded ringtone records 212.The alarm of step 2112 may be rendered by the cellular telephone 114generating a sound energy as derived from a digitized alarm tone record214, wherein the sound generated is distinctive to the patient 88 fromthe sounds generated by the cellular telephone by rendering from one ofthe ringtones records 212. Alternatively or additionally, the alarm ofstep 2112 may direct the cellular telephone 114 to energize thevibration module 166 with the aim to attract the attention of thepatient 88.

The medical advice transmitted and received by the cellular telephone114 in step 2116 may be included in whole or in part in an audio message216 that may be rendered by audible output module 152 for the patient 88to listen to, and/or by a textual message 218 that the patient 88 mayread from the display screen 128.

Additionally or alternatively, the textual message 218, some or all ofthe therapeutic advice of step 2116, and/or the alarm 2112 may betransmitted to the cellular telephone 114 by means of a text messagingservice or a small message service as received and rendered by the SMSmodule 168 of the cellular telephone 114 and enabled via the TELCO 112by a telephone services provider, for example, AT&T (™) text messagingservice or small message service provider.

Referring now generally to the Figures and particularly to the FIGS. 3and 22, in yet another alternate or additional method, the diagnosticianapplies in the process of FIG. 22 an activity monitor process of thediagnostic system 110 to generate a communications activity baseline 220of telephone communications and compares the baseline with a calculationof recent telephone communications to generate a current communicationsfrequency to determine if the current telephone use of the patient 88 isindicative of an increased risk of the patient entering into a decliningstate of mental health, for example, in certain circumstances, decreasedsociability may be an early indicator of declining mental state or otherconditions. In step 2202 the diagnostic system 110 counts the number ofphone calls C1 placed by the patient 88 over a first length of time T1,for example, over the preceding three months. In step 2204 thediagnostic system 110 calculates a baseline ratio R1 of placed phonecalls C1 as divided the first length of time T1. The baseline ratio R1is thus one instantiation of the communications activity baseline 220.

In step 2206 the diagnostic system 110 determines the number oftelephone calls C2 placed by the patient 88 over a shorter and morerecent second period of time T2, for example, over the most recentfive-day period. In step 2208 the diagnostic system then calculates acurrent ratio R2 equal to the number of more recently placed phone callsC1 as divided the second length of time T2.

In step 2210 the diagnostic system 110 divides the current ratio R2 bythe baseline ratio R1 and determines whether the result of this divisionis less than a first indicator value V1 of, for example, 0.70. In oneexemplary application of the process of FIG. 22, the first indicatorvalue V1 is 0.70, the first ratio R1 indicates the number of telephonecalls placed by the patient 88 via the cellular telephone 114 per unittime during the most recent three months, and the second ratio R2indicates the number of telephone calls placed by the patient 88 via thecellular telephone 114 per unit time during the most recent five dayperiod, whereby if the frequency of phone call placed by the patient 88dips below 70% of the frequency of telephone calls exhibited by thepatient 88 in the most recent three month period, the diagnostic system110 issues an alert to patient 88 in step 2212 as described above in theprocess of FIG. 21. It is understood that the alert of step 2212 may beissued by either direction of the diagnostician or by an automaticactivity monitor logic 223 of the diagnostic system 110. It is furtherunderstood that the activity monitor logic 223 may calculate C1 and/orC2 by calculated number of telephone calls placed from the cellulartelephone 114 summed with the number of telephone calls received throughthe cellular telephone 114. It is further understood that the activitymonitor logic 223 may calculate C1 and/or C2 by including the number ofattempted telephone calls placed from the cellular telephone 114. It isfurther understood that the activity monitor logic 223 may calculate C1and/or C2 by additionally or alternately by counting the number of textmessages sent to and/or from the cellular telephone 114.

It is further understood that the diagnostician may provide therapeuticguidance to the patient 88 as an element of the transmitted alarm ofstep 2212 in steps 2210 through 2216, as per steps 2112 through 2116 ofFIG. 21.

Referring now generally to the Figures and particularly to FIG. 23, FIG.23 is a schematic of a diagnostic system software 222 of the diagnosticsystem 110. The diagnostic system software 222 includes a diagnosticsystem operating system 224 and the patient DBMS 40 that stores aplurality digitized software encoded records of one or more ringtonesrecords 212, alarm tone records 214, audio message records 216, and/ortext messages 218 that may be transmitted via the network 2 to thecellular telephone 114. The patient DBMS 40 may include a plurality ofcall records 226.A-226.N, a plurality of GPS records 228.A-228.N, aplurality of text messages records 230.A-230.N and the GPS baseline data220. The plurality of call records 226.A-226.N, plurality of GPS records228.A-228.N and plurality of text message records 218 may be provided tothe diagnostic system 110 via the network 2 by the TELCO 112 and/or thetelecommunications network services provider.

Referring now generally to the Figures and particularly to FIGS. 24A,24B and 24C, FIG. 24A is a schematic diagram of an exemplary first phonecall record 224.A selected from the plurality of call records226.A-226.N provided by or the via the TELCO 112 by the telephoneservices provider. Each phone call record 226.A-226.N containsinformation related to an individual communication session that isenabled by the network 2. It is understood that a communication sessionmay be enabled by the Internet 2B by voice over Internet Protocoltechnology and/or by the telephony network 2B. The information containedwithin the plurality of phone call records 226.A-226.N may be providedby or via the TELCO 112 by the telephone services provider in whole orin part.

The exemplary first call record 226.A relates to a first communicationssession, for example, an “instant communications session”. A phoneidentifier 226.A.1 identifies the cellular telephone 114. The phoneidentifier 226.A.1 may be, for example, a telephone number or a networkaddress, or may be another telephone (not shown) or a network address ofa computer 106, 116. A second phone identifier 226.A.2 identifies asecond telephone (not shown) or a computer 106 or 116. It is understoodthat the second phone identifier 226.A.2 may be a telephone number or anetwork address, or may be a reference number to the second telephone ora computer 106 or 116 that is issued to protect the privacy of anotherparty. An origin flag 226.A.3 indicates whether the instantcommunications session was initiated by the means of either (a.) thecellular telephone 114, or (b.) the computer 106 or other computer 116.A call start data 226.A.4 identifies the start time of the instantcommunications session. A call duration data 226.A.5 documents thelength of time of the instant communications session. A GPS data 226.A.6includes a global position system data that indicates the location ofthe cellular telephone 114 at the start time of the instantcommunications session or at a moment during the duration of the instantcommunications session. The GPS data 226.A.6 may be generated by the GPSmodule 156 of the cellular telephone 114 in concert with informationreceived from a global positioning system.

Referring now generally to the Figures and particularly to FIG. 24B,FIG. 24B is a schematic diagram of an exemplary first GPS record 228.A.A phone identifier 228.A.1 identifies the cellular telephone 114. A GPSsampling data 228.A.2 includes a global position system data thatindicates the location of the cellular telephone 114. A GPS time data228.A.3 indicates a time and date that the GPS sampling data 228.A.2 wasacquired by the cellular telephone 114.

Referring now generally to the Figures and particularly to FIGS. 24C,FIG. 24C is a schematic diagram of an exemplary first text messagerecord 228.A selected from the plurality of text session records230.A-230.N. Each text record 230.A-230.N contains information relatedto an individual texting session that is enabled by the network 2. It isunderstood that a communications session may be enabled by the Internet2B by various technologies, for example, Voice Over Internet Protocol(VOIP) technology, the telephony network 2A, etc. The informationcontained within the plurality of text records 230.A-230.N may beprovided by or via the TELCO 112 by the telephone services provider inwhole or in part.

The exemplary text session record 230.A relates to a first text session,i.e., an “instant text session”. A phone identifier 230.A.1 identifiesthe cellular telephone 114. A second phone identifier 230.A.2 identifiesa second telephone (not shown) or a computer 106 or 116 thatparticipated in the instant text message. A text time data 230.A.3identifies a time of initiation or completion of the instant textmessage session. An origin flag 230.A.4 indicates whether the instantcommunications session was initiated by the means of either, forexample, (a.) the cellular telephone 114, or (b.) the computer 106 orother computer 116.

Referring now generally to the Figures and particularly to FIG. 25, FIG.25 illustrates a still other additional or alternate method, wherein GPSdata collected from the cellular telephone 114 of the patient 88 is usedto determine the current and relative level of social interaction inwhich the patient 88 is engaging. In step 2502 the cellular telephone114 is associated with the patient 88 and monitored. The GPS module 156of the cellular telephone 114 is periodically sampled and each sampledGPS datum is recorded in an individual GPS record 228.A-228.N of thepatient DBMS 40. The monitoring of the use of the cellular phone 114 maybe provided by or via the TELCO 112 by the telephone services providerin whole or in part, for example, in step 2504 during a phone session,from which the patient 88 receives a text enabling service and/or bymonitoring by the wireless comms system 120, etc. The GPS records228.A-228.N and the patient database 40 are transmitted to, stored in,and made accessible for review to a diagnostician at the diagnosticsystem 110 and/or the data base computer 108. The diagnosticiandetermines in step 2508 that the level of social interaction indicatesan increased risk of degradation in the state of mental health of thepatient 88, the diagnostician then determines in step 2510 whether ornot to issue an alarm to alert the patient 88 or third parties of apotential decline in mental health. An alarm is transmitted to andrendered in step 2512 by the cellular telephone 114 in optional step2512. Additionally or alternatively, the diagnostician may in step 2514generate a therapeutic recommendation, for example, a diagnosis of, or aprescription regarding, one or more health issues of the patient 88 instep 2514, and optionally the medical advice generated in step 2516 istransmitted to and rendered by the cellular telephone 114. It isunderstood that either or both the alarm transmitted and rendered instep 2512 and the advice transmitted and rendered in step 2516 mayoptionally, alternatively or additionally be sent to and rendered by thecellular telephone 114, the first network computer 106, thewireless-communications enabled network computer 116 and/or thewireless-communication enabled personal digital assistant 118 in wholeor in part.

It is understood that the cellular telephone 114 may have a plurality ofpre-recorded standard ringtones records 212. The alarm of step 2112 maybe rendered by the cellular telephone 114 generating a sound energy asderived from an alarm tone record 212, wherein the sound generated isdistinctive to the patient 88 from the sounds generated by the cellulartelephone 114 by rendering from one of the ringtones records 214.Alternatively or additionally, the alarm of step 2512 may direct thecellular telephone 114 to energize the vibration module 166 with the aimto attract the attention of the patient 88.

The medical advice transmitted and received by the cellular telephone114 in step 2516 may be included in whole or in part in an audio messagerecord 216 that may be rendered by audible output module 152 for thepatient 88 to listen to, and/or by a textual message record 230 that thepatient 88 may read from the display screen 128.

Additionally or alternatively, the textual message 230, some or all ofthe therapeutic advice of step 2116, and/or the alarm 2112 may betransmitted to the cellular telephone 114 by means of a text messagingservice or a small message service as received and rendered by an SMSmodule 168 of the cellular telephone 114 and may be provided in whole orin part by or via the TELCO 112 by the telephone services provider.

Referring now generally to the Figures and particularly to the FIG. 26,in yet another additional or alternate method, the diagnostician appliesa mobility monitor logic 232 of the diagnostic system 110 to generatethe GPS baseline 220 derived from the telephone GPS information of theplurality of GPS records 226.A-226.N and compares the GPS baseline 220with a more recent plurality of GPS readings to determine if themobility of the patient 88 is indicative of an increased risk of thepatient entering into a reduced state of mental health. In step 2602 thediagnostic system 110 examines the GPS records 228.A-228.N containingGPS information collected over an extended length of time T3, forexample, over the preceding three months. In step 2604 the diagnosticsystem 110 calculates the GPS mobility baseline 220 indicative of themovement presented by the patient 88 during the extended time C3, forexample, an extended mobility value M1.

In one alternate aspect of the method of FIG. 26, the mobility baseline220 is automatically calculated by (a.) selecting a plurality of GPSrecords 228.A-228.N; (b.) ordering the GPS records 228.A-228.N in orderof the GPS time data 228.A.3-228.N.3; (c.) calculating the distancebetween each ordered GPS records 228.A-228.N by straight linemeasurements between succeeding each ordered GPS location data228.A.2-228.N.2; (d.) summing the distances measured in the previousstep; and dividing the distance measurement by a length time measuredbetween the earliest GPS time data 228.A.3-228.N.3 and the most recentGPS time data 228.A.3-228.N.3 of the selected plurality of GPS records228.A-228.N.

In step 2604 the diagnostic system 110 examines the GPS records228.A-228.N containing GPS information collected over a shorter andrecent mobility period of time T4, for example, over the most recentfive day period, and calculates a recent mobility value M1 in step 2604.In step 2606 the diagnostic system 110 examines the GPS records228.A-228.N containing GPS information collected over a greater periodof time and calculates an extended time period mobility value M2.

In step 2608 the diagnostic system 110 calculates a current mobilityratio R3 equal to the recent mobility value M1 divided by the extendedmobility value M2.

In step 2610 the diagnostic system 110 compares the current mobilityratio R3 to a level L. In one exemplary application of the measurementof the patient's recent mobility dips below 70% the patient's estimatedmobility as expressed by the mobility baseline 220, the diagnosticsystem 110 issues an alert to patient 88 in step 2612 as described abovein the process of FIG. 25. It is understood that the alert of step 2612may be issued by either direction of the diagnostician or by themobility monitor logic 232. It is further understood that thediagnostician may provide therapeutic guidance to the patient 88 as anelement of the transmitted alarm of step 2612 in steps 2620 through2216, and as per steps 2512 through 2520 of FIG. 25.

Referring now generally to the Figures and particularly to FIG. 27, FIG.27 is a process chart of an even other additional or alternate method,wherein the cellular telephone 114 is programmed to render a distinctiveringtone record 212, alarm tone record 214, audio message record 216,and/or text message record 218 to alert the patient 88 to take amedication, engage in a medically recommended behavior, or cease abehavior. In step 2702 the cellular telephone 114 determines if aprogrammer, for example, the patient 88, the diagnostician, a healthcare provider, or other party, has input a command to place the cellularphone 114 into an alert programming mode. When the cellular telephone114 determines in step 2702 that the programmer has input a programmingcommand, the cellular telephone 114 proceeds to step 2704 and accepts aselection of an alert selection from the programmer, where the alertselection may be indicated from a group including for example, but notlimited to, a distinctive ringtone record 212, alarm tone record 214,audio message record 216, and/or text message record 218. In step 2706the cellular telephone 114 accepts an alert time from the programmerwhich indicates at which time the cellular telephone 114 is to renderthe selected alert. The cellular telephone 114 proceeds from step 2706to step 2708 to access the date/time circuit 162 and in step 1610 todetermine whether the alert time has passed. When the cellular telephone114 determines in step 2710 that the alert time has occurred, thecellular telephone 114 proceeds on to step 712 and renders the selectedalarm, wherein such rendering may include an excitation of, for example,the vibration module 166, a sound generated from ringtone record 212,alarm tone record 214, and/or audio message record 216 by means of theaudio output module 152, and/or text message record 218 by means of thedisplay device 156. The cellular telephone 114 proceeds from either step2710 or step 2712 to determine whether to cease the alert cycle in step2714. When the cellular telephone 114 determines in step 2714 to ceasethe alert cycle of steps 2708 and 2710, the cellular telephone 114proceeds on to step 2716 and performs additional or alternatecomputational operations, which may include a return to step 2702 at alater time. When the cellular telephone 114 determines in step 2714 tocontinue to execute the alert cycle of steps 2708 through 2714, thecellular telephone 114 proceeds on to step 2718 and performs additionalor alternate computational operations before performing anothercomparison of the programmed alert time of step 2710 with the real timeas indicated by a current output of the date/time circuit 162 executionof step 2708.

It is understood that the alert rendered in step 2710 may encourage thepatient to inhale a second medication 240 or to apply a topicalmedication 242 to a skin area 244 of the patient 88.

Referring now generally to the Figures and particularly to FIG. 28, FIG.28 illustrates a still further alternate additional or alternate method,wherein the cellular phone 114 is programmed to remind the patient 88 totake, for example, ingest, inhale, insert or topically apply, etc., oneor more medications 126. The phone 114 initializes a resting timevariable TD to a current date and time reading received from thedate/time circuit 162 in step 2802. The phone 114 then proceeds to step2804 to perform alternate computational operations, and periodicallyreturns to step 2806 to determine whether to query the accelerometer 170to determine whether the accelerometer 170 has detected motion since themost recent execution of step 2802. When the phone 114 determines instep 2806 that the accelerometer 170 indicates motion of the phone 114since the most recent execution of step 2802, the phone 114 proceeds onto step 2808 to determine whether the time elapsed between the currentvalue of the resting time variable TD and a newer and actual date andtime reading TA received from the date/time circuit 162 is greater thana sleep time value TS, for example, wherein the sleep time value is avalue preferably between the time durations of four hours and eighthours. When the phone 114 determines in step 2808 that the accelerometer170 has not detected motion for a period of time greater than the sleeptime value TS, the phone 114 proceeds on to step 2810 and to render analert to encourage the patient 88 to take one or more medications, e.g.,medicine 126, 240 and 242.

It is understood that the motion detector 23 of FIG. 1 may be, include,or be comprised within, an accelerometer 170, a GPS module 156, or acellular telephone 114.

When the cellular telephone 114 determines in step 2808 that the alerttime has occurred, the cellular telephone 114 proceeds on to step 2810and renders the selected alarm, wherein such rendering may include, forexample, an excitation of the vibration module 166, a sound generatedfrom ringtone record 212, alarm tone record 214, and/or audio messagerecord 216 by means of the audio output module 152, and/or text messagerecord 218 by means of the display device 156.

The cellular telephone 114 proceeds from either step 2810 or step 2812to determine whether to cease the alert cycle of steps 2800 through2812. When the cellular telephone 114 determines in step 2812 to ceasethe alert cycle of steps 2800 through 2812, the cellular telephone 114proceeds on to step 2814 and performs additional or alternatecomputational operations, which may include a return to step 2802 at alater time.

Referring now generally to the Figures and particularly FIG. 29, FIG. 29is a schematic of a first exemplary patient record 232.A selected from aplurality of patient records 232.A.1-232.A.N that are stored in thepatient DBMS 40 and/or the mobile DBMS 200 as stored in the cellulartelephone 114, the DB computer 108, and/or the diagnostic system 110.The first exemplary patient record 232.A includes a patient identifier232.A.1, a phone identifier 232.A.2, a biometric data field 232.A.3, aningestion record 232.A.4, a patient reminder instructions data field232.A.5, and a behavior data field 232.A.6. The patient identifier232.A.1 uniquely identifies the patient 88 to the DBMS 178 and 206. Thephone identifier 232.A.2 uniquely identifies the phone 114 to the DBMS178 and 206. The biometric data field 232.A.3 includes biometric datareceived from the sensors 20-23 and 98-104 with associated time datestamps generated by the time/date circuit 162 wherein each date timestamp individually identifies the time of generation of an associatedbiometric datum. The ingestion record 232.A.4 includes data identifyingmedicines taken, for example, inhaled, applied, inserted, ingested,etc., with associated time date stamps generated by the time/datecircuit 162 wherein each date time stamp individually identifies thetime of generation of a comprising ingestion record. The patientreminder instructions data field 232.A.5 includes instructions directingthe phone 114 to when and how to render an alert to encourage thepatient 88 to perform a specified meditative practice, a relaxationpractice, and/or a therapeutic behavior. The behavior data field 232.A.6includes data noting a performance of a meditative practice, arelaxation practice, a therapeutic behavior, and/or other practice orbehavior of the patient 88, with associated time date stamps generatedby the time/date circuit 162 wherein each date time stamp individuallyidentifies the time of the referenced performance or behavior.

Referring now generally to the Figures and particularly to FIG. 30, FIG.30 illustrates an even additional or alternate method, wherein a patientrecord 232.A-232.N is applied by the phone 114 to record biometric datareceived from one or more sensors 20-23 and 98-104 and to send alerts toencourage the patient 88 to perform meditative exercises, relaxationexercises, or other therapeutic behaviors. In step 3002 the phone 114receives notice of a taking of a medication, e.g., medicine 126, 240 or242, and records the medicine application datum with an associated timedate stamp in the ingestion records data field 232.A.4 of the exemplaryfirst patient record 232.A. In step 3004 the phone 114 issues an alertto the patient in accordance with information stored in the remindermessage instructions 232.A.5. In step 3006 the phone 114 receives abiometric datum received from one or more sensors 20-23 and 98-104, andrecords the received biometric datum with an associated time date stampin the biometric data field 232.A.3. It is understood that the biometricdatum might be (a.) a measure of blood pressure or hypertensiongenerated by and received from the blood pressure sensor 90; (b.) ameasure of heart rate generated by and received from the heart ratesensor 94; (c.) a measure of body temperature generated by and receivedfrom the temperature sensor 98; and/or (d.) a measure of respirationgenerated by and received from the respiration sensor 102.

In step 3008, the data stored in the exemplary first patient data record232.A is visually presented to the patient 88 via the display screen 128by the GUI driver 198 and optionally as described in reference to FIG.18. This presentation of step 3008 is executed with the intent toprovide feedback to the patient 88 of the effect that the behavior ofthe patient 88 is having on the physiological state of the patient 88,whereby the patient 88 is encouraged to follow the practices. e.g.,making a pause, avoiding a situation, taking a pill, etc., to achieve aprescribed behavior, e.g., cool, calm, composed, etc., and behaviorspecified by the reminder message instructions 232.A.5.

The phone 114 determines in step 3010 whether to continue performing thecycle of steps 3000 through 3008, or to proceed on to alternatecomputational processes of step 3014. When the phone 114 determines instep 3010 to continue performing the cycle of steps 3000 through 3008,the phone proceeds on to step 3012 and to determine whether instructionsto the patient 88 of a dosage of a medicine 126, 240 and 242, a scheduleof taking a medicine 126, 240 and 242, or a recommended patient practiceor behavior. When a therapeutic alteration is determined in step 3012,the phone 114 proceeds on to step 3016 and to alter information storedin the reminder message instructions 232.A.5. The phone 114 thenproceeds from step 3016 on to step 3002.

It is understood that the biometric datum received in one or moreexecutions of step 3006 may be received by (a.) wireless transmissionsfrom the wireless comms system 120, and/or a wireless enabled sensor20-23, 90, 94, 98 and 102; and/or (b.) a hardwired connection with thenetwork 2. It is further understood that a notice of an ingestion of thecomposition device 122 may be received by the phone 114 as transmittedwirelessly from the IEMD 4 and/or the wireless comms system 120.

It is additionally understood that the alteration of information storedin the reminder message instructions 232.A.5 as performed in step 3016may be directed and provided by a health care professional as input fromthe DB computer 108 and/or the diagnostic system 110.

Referring now generally to the Figures and particularly to FIG. 31, FIG.31 describes another additional or alternate method, wherein high stressevents that occur routinely in the life of the patient are identifiedand the phone 114 is programmed to encourage the patient 88 to follow orperform therapeutic or prescribed steps or instructions to reduce theharmful impact of the stress inducing events. In step 3102 a pluralityof patient records 232.A-232.N are formed by observing and storing thereadings of the sensors 20-23, 90, 94, 98 and 102. In step 3104 patientactivity logs 168 are formed and populated with data, wherein thepatient 88 records time and dates and descriptions of daily eventsexperienced by the patient 88. The patient activity logs 168 may bepopulated from inputs by the patient 88 to the phone 114, the PDA 118,and/or the wireless computer 116. The diagnostician or other health careprofessional analyzes the plurality of patient logs 232A-232N incomparison with the patient records 232.A-232.N to isolate and findpatterns between sensory indications of physiological stress experiencedby the patient 88 and predictable events in the life of the patient,e.g., meetings with supervisors, subordinates, or family members. Thediagnostician or health care professional then determines those eventsthat can be anticipated and lead to high stress conditions for thepatient 88 in step 3108. The diagnostician then programs the phone 114to issue a message to the patient prior to one or more anticipatedstress-inducing event. The diagnostician or health care professionalprograms the phone 114 in step 3110 via the diagnostic system 110 andthe network 2. The diagnostician or health care professional determinesin step 3112 whether to continue the loop of steps 3102 to 3112 or toproceed on to alternate processes of step 3114.

FIG. 29 is a schematic of an exemplary patient activity log 232A thatincludes the patient ID 232.A.1, the phone ID 232.A.2, and a pluralityof activity notes 232A.1-232A.N. Each activity note 232A.1-232A.Ncontains a notation by the patient 88 of the date, time and nature of anactivity experienced by the patient 88, e.g., arrival at work, commutingexperiences, physical exercise, social interactions, and work relatedbehavior.

Referring now generally to the Figures and particularly to FIG. 32, FIG.32 describes a yet additional or alternate method, wherein thediagnostician analyzes information about diagnostic test results,genetic test results, patient records 232.A-232.N, patient activity logs232A-232N, and other information to develop and prescribe therapy. Oneor more diagnostic tests are performed in step 3202. The results ofthese diagnostic tests are stored in the diagnostic system 110 in step3204 in one or more diagnostic test records 236.A-236.N. One or moregenetic tests are performed in step 3206. The results of these genetictests are stored in the diagnostic system 110 in step 3208 in one ormore genetic test records 252.A-252.N. The diagnostician then analyzesthe diagnostic test records 236.A-236.N, the genetic test records252.A-252.N, the patient records 232.A-232.N, the patient activity logs232A-232N, and other information in step 3210 by means of the diagnosticsystem 110. The diagnostician then updates a therapeutic plan in step3212, and programs the cell 114 to transmit alerts and alarms to thepatient 88 in step 3314 that are designed to encourage the patient 88 tocomply with the prescribed therapy of step 3312.

The diagnostician or health care professional determines in step 3316whether to continue the loop of steps 3302 to 3316 or to proceed on toalternate processes of step 3318.

FIG. 34 is a schematic of an exemplary first diagnostic test record236.A that includes the patient ID 232.A.1, the phone ID 232.A.2, and aplurality of diagnostic test notes 236.A.1-236.A.N. Each diagnostic testnote 236.A.1-236.N contains information identifying a diagnostic test, atime and date of the diagnostic test, and the results of the diagnostictest.

FIG. 35 is a schematic of an exemplary first genetic test record 238.Athat includes the patient ID 232.A.1, the phone ID 232.A.2, and aplurality of genetic test notes 238.A.1-238.A.N. Each genetic test note238.A.1-238.N contains information identifying a genetic test, a timeand date of a performance of the genetic test, and the results of thegenetic test.

FIG. 36 is a schematic illustrating the diagnostic system software 222as containing the patient records 232.A-232.N, the patient activity logs234.A-234.N, the diagnostic records 236.A-236.N and the genetic records238.A-238.N.

FIG. 37 is a schematic of the patient 88 being monitored by additionalsensors 240 and 242. An impedance sensor 240 is in contact with a secondskin area 244 of the patient. The impedance sensor 240 is configured andpositioned to detect variations in dermal impedance of the patient 88that are generally determined by sweat forming on the second skin area244. An electrocardiograph sensor 242 (or “ECG sensor” 242) isconfigured and positioned relative to the patient 88 to measure theelectrical activity of the heart 246 of the patient 88.

FIG. 38 is a schematic diagram of the exemplary heart rate sensor 94.The heart rate sensor 94 includes a biometric detector 94A, a logiccircuit 94B, a wireless interface 94C, a signal emitter 94D, and abattery 94E that are all mounted onto a flexible band 94F. The biometricsensor 94A monitors and measures the heart rate of the patient 88 andcommunicates the heart rate measurement to the logic circuit 94B. Thelogic circuit 94B formats and populates a biometric data message anddirects the wireless interface 94C to transmit the biometric message ina wireless transmission via the emitter 94D. It is understood that theemitter 94D may be a radio wave antenna or a light pulse emitter. Theemitter 94D is configured to transmit the biometric message forsuccessful reception by the phone 114, the wireless computer 116, thePDA 118 and/or the wireless comms system 120. The battery 94E provideselectrical power to the biometric detector 94A, the logic circuit 94B,the wireless interface 94C and the signal emitter 94D.

A first strap 94G and a second strap 94H are each separately coupledwith the flexible band and enable the heart rate sensor to be detachablycoupled to the patient 88. A first hook and loop fabric strip 941 and asecond hook and loop fabric strip are positioned to detachably engageand hold the flexible band 94E against a skin area 163 and 176 of thepatient 88. Alternatively or additionally an adhesive strip 94L of theflexible band 94F is configured and positioned to enable detachableplacement of the flexible band against a skin area 163 and 164 of thepatient 88.

It is understood that the illustration of the heart sensor 94 of FIG. 37is exemplary and is descriptive in part of other sensors 20-23, 94, 98,102, 240 and 242.

Referring now generally to the Figures and particularly to FIG. 39, FIG.39 illustrates another still additional or alternate method, wherein thediagnostician receives and analyzes information and advises the patient88 with therapeutic guidance. In step 3902 the phone 114 receivesaccelerometer data from the accelerometer 170. The phone 114 transmitsthe received accelerometer data to the diagnostic system 110 in step3904, wherein the accelerometer data is stored in a movement record248.A-248.N. The diagnostic system 110 calculates a walking gait of thepatient 88 by analyzing a plurality of movement records 248.A-248.N andstores the gait calculation in step 3906. The phone 114 receives skinimpedance data from the impedance sensor 240 and transmits the receivedimpedance data to the diagnostic system 110 in step 3908. The phone 114receives electrocardiograph data from the ECG sensor 242 and transmitsthe received electrocardiograph data to the diagnostic system 110 instep 3910. The phone 114 receives body temperature data from thetemperature sensor 98 and transmits the received body temperature datato the diagnostic system 110 in step 3912.

The diagnostic system 110 displays the gait calculated and the datareceived in steps 3904, and 3908-3912 to the diagnostician in step 3914on the display screen 128 as rendered by the GUI driver 176. Thediagnostician analyzes the displayed information and communicatesdiagnostic information, prognostic information, and therapeutic guidanceto the patient in step 3916 via the network 2.

The diagnostician determines in step 3918 whether to continue the loopof steps 3902 through 3918 or to proceed on to alternate activities ofstep 3920.

Referring now generally to the Figures and particularly to FIGS. 22 and40, FIG. 40 illustrates another even additional aspect of a method,wherein the patient is encouraged by yet other engagement modalities toadhere to a prescribed ingestion of the medicine 126. In step 4002 thephone 114 determines whether the IEMD 4 has emitted an ingestion signal.When the phone 114 determines in step 4002 that the IEMD 4 has emittedan ingestion signal, the phone 114 informs the DB computer 108 via thenetwork 2 in step 4004 an ingestion signal has been received. The DBcomputer 108 then updates a virtual pet status in step 4006 inaccordance with the information transmitted in step 4004. The virtualpet status is an aspect of a virtual pet personality software 254 ismaintained by a virtual world web service 256 that is hosted on avirtual world services server 258. The virtual world services server 258is accessible to the phone 114 through the network 2, and the virtualpet personality software 254 maintains status and conditions on thebasis of instructions from the virtual world web service 256 and fromthe patient 88 and the DB computer 108 as delivered via the network 2 tothe virtual world services server 256.

The DB computer 108 further determines in step 4008 whether with theinformation transmitted in step 4004 in combination with additionalinformation related to the patient and stored in the patient data base40 indicates that the patient 88 has earned a reward or achieved a newreward state or level. When the DB computer 108 determines in step 4008that the patient 88 has earned a reward, the reward is issued in step4010. The reward of step 4010 may be as modest as directing the phone114 to vibrate, visually display a congratulations message, and/orrender a pleasant audible tone or musical tune. The reward of step 4010may also include making provisions for delivery of a physical coin,medallion, or crystal. The reward of step 4010 may alternatively oradditionally include (a.) providing the patient 88 with a ringtone dataor file; (b.) rewarding the patient 88 with a music download service atno extra charge; and/or (c.) a delivery of a hard copy note ofcongratulations. In various aspects, the rewards may be provided by, orotherwise associated with, one or more reward/incentive sources. Suchsources may include, for example, proprietary reward systems, e.g.,developed in conjunction with or for aspects of the invention, andexisting reward systems, e.g., commercial incentive or reward systemssuch as point systems, coupon systems, etc., associated with one or moreindependent providers.

In optional step 4012 the DB computer 108 informs an online community ofthe achievement and/or status of the patient 88 via the network 2. TheDB computer 108 in step 4014 whether to continue the loop of steps 4002through 4014 or to proceed on to perform alternate computationalactivities of step 4016.

Referring now generally to the Figures and particularly to FIG. 41, FIG.41 illustrates another even additional process wherein the patchreceiver 122 is attached or coupled to the patient 88, or clothing orpersonal equipment of the patient 88 in step 4102. The biometric datareceived by the patch receiver 122 is monitored during a first timeperiod T1 in step 4104. The biometric data received in step 4104 isstored in the patient database 40 in step 4106. The biometric datareceived by the receiver patch 122 is then monitored during a secondtime period T2 in step 4108. In step 4110 the biometric data received bythe path receiver 122 e.g., from the one or more IEMD 4, during thefirst time period T1 and second time period T2 is compared by adiagnostician and/or the activity monitor logic 223. The diagnosticianand/or the activity monitor logic 223 then determines in step 4112whether a predetermined action shall be taken at least partly on thebasis of the comparison of step 4112 of the behavior of the one or moreIEMD 4 that transmit an ingestible event marker datum IEM M during thefirst time period T1 and the second time period T2. The predeterminedaction, such as transmitting an alert to the patient 88 via the cellulartelephone 114 or informing a healthcare provider of the state of thepatient 88, is affected in step 4114.

In various aspects, a system is provided, for example and as illustratedin FIG. 42, a system 4200 may include a biometric information module4202 to receive biometric information associated with an ingestibleevent marker datum IEM M; an analysis module 4204 to analyze thebiometric information; and a determination module 4206 to determine atherapeutic recommendation at least partly on the basis of the analysis.Biometric information includes any data and/or information associatedwith living being, e.g., physiologic information such as heart rate,blood pressure, etc.; subA skilled artisan will recognize that themodules may be standalone or integrated in various combinations.Further, one or more modules may be implemented as software modules, ashardware, as circuitry, etc.

FIG. 43 illustrates a unified system 4300 to facilitate adherence to atreatment plan which may include a biometric information module 4202 toreceive biometric information associated or contained within aningestible event marker datum IEM M; an analysis module 4204 to analyzethe biometric information; and the determination module 4206 todetermine a therapeutic recommendation at least partly on the basis ofthe analysis. The patient management data system 10 is optionallycomprised within the unified system 4300 and may be communicativelycoupled with all other parts of the unified system 4300 via acommunications bus 4302. Further, one or more modules 4202, 4204, 4206and PMDS 10 may be implemented as software modules, as hardware, ascircuitry, etc.. Referring now to FIG. 2, in certain alternateconfigurations, the unified system 4300 may be, in whole or in part,comprised within the PMDS 10.

In addition, one or more modules may be associated with one or moredevices. To illustrate, a receiver or computer may be associated withthe biometric information module 4202 of the unified system 4300. One ormore modules 4202, 4202, 4206 and PMDS 10 may be associated with acomputer, a network, the internet 2B, the telephony network 2A, adatabase computer 108, a database 40, an ingestible event device IEMD 4,an ingestible event marker datum IEM M, a receiver, e.g., a receiverassociated with an IEMD 4 or other device, a wireless computer 116; atemperature sensor, a respiration sensor, a pressure sensor, a heartsensor, and/or other devices and systems.

While the present invention has been described with reference tospecific methods, devices and systems, it should be understood by thoseskilled in the art that various changes may be made and equivalents maybe substituted without departing from the true spirit and scope of theinvention. In addition, many modifications may be made to adapt aparticular situation, material, composition of matter, process, processstep or steps, to the objective, spirit and scope of the presentinvention. All such modifications are intended to be within the scope ofthe claims appended hereto.

The foregoing disclosures and statements are illustrative only of thepresent invention, and are not intended to limit or define the scope ofthe present invention. The above description is intended to beillustrative, and not restrictive. Although the examples given includemany specificities, they are intended as illustrative and not limiting.Those skilled in the art will appreciate that various adaptations andmodifications of the just-described systems and methods can beconfigured without departing from the scope and spirit of the presentinvention. Therefore, it is to be understood that the present inventionmay be practiced other than as specifically described herein. The scopeof the present invention as disclosed and claimed should, therefore, bedetermined with reference to the knowledge of one skilled in the art andin light of the disclosures presented above.

1-20. (canceled)
 21. A system, comprising: a sensor coupled to a body ofa patient, wherein the sensor is configured to detect physiologic datafrom the body of the patient and wirelessly transmit the physiologicdata; an electronic communication device associated with the patient,wherein the electronic communication device comprises a patient inputdevice; and a computer system communicatively coupled to the electroniccommunication device, wherein the computer system comprises: a patientrecord associated with the patient, wherein the patient recordindicates: patient activity data comprising a plurality of proposedactivities of the patient, wherein each proposed activity is associatedwith a proposed time to engage in its associated proposed activity; anddetected physiological data received from the sensor via the electroniccommunication device; wherein the computer system is configured to:compare the detected physiological data of the patient record to a rangeof healthy values, associated with the physiological data, to identifyan unhealthy physiological data value; correlate the identifiedunhealthy physiological data value to a proposed activity of the patientactivity data; select a therapeutic recommendation to bring theidentified unhealthy physiological data value within the range ofhealthy values associated with the physiological data; and transmit theselected therapeutic recommendation to the patient, via the electroniccommunication device, at a future proposed time associated with thecorrelated proposed activity.
 22. The system of claim 21, wherein one ormore than one of the plurality of proposed activities of the patientactivity data is received via the patient input device.
 23. The systemof claim 21, wherein the plurality of proposed activities are associatedwith at least one of a work task, a physical exercise, a stress inducingevent, a hobby, a recreational activity, a meal consumption, a liquidingestion, a social interaction, or an erotic act.
 24. The system ofclaim 21, wherein the patient record of the computer system furtherindicates: attestation data received via the patient input device,wherein the attestation data comprises at least one attestationassociated with a change to a proposed activity of the plurality ofproposed activities; and wherein the computer system is furtherconfigured to: correlate the identified unhealthy physiological datavalue to a changed activity associated with the attestation data; andtransmit the selected therapeutic recommendation to the patient, via theelectronic communication device, at a future proposed time associatedwith the correlated changed activity.
 25. The system of claim 21,wherein the computer system is further configured to: compare thedetected physiological data to the plurality of proposed activities ofthe patient activity data to identify patterns between unhealthyphysiological data values and proposed activities of the patient; andtransmit a therapeutic recommendation to the patient, via the electroniccommunication device, prior to a proposed activity having an identifiedpattern to an unhealthy physiological data value.
 26. The system ofclaim 21, wherein the computer system is further configured to: comparethe detected physiological data to the plurality of proposed activitiesof the patient activity data to identify patterns between unhealthyphysiological data values and routine activities of the patient; andtransmit a therapeutic recommendation to the patient, via the electroniccommunication device, prior to a routine activity having an identifiedpattern to an unhealthy physiological data value.
 27. The system ofclaim 26, wherein the routine activity is a stress-inducing activity.28. The system of claim 21, further comprising: a plurality ofingestible event markers (IEMs), wherein each IEM is stably associatedwith a medication, wherein each IEM is configured to generate ingestiondata and wirelessly transmit the ingestion data after contact withbodily fluid of the patient at a target physiological site, and whereinthe ingestion data comprises an identification of the medication and atime of the ingestion; wherein the patient record of the computer systemfurther indicates: a prescribed medication of the patient, wherein theprescribed medication is associated with a medication schedule includingprescribed times to administer the prescribed medication; and ingestiondata received from one or more than one IEM ingested by the patient viathe electronic communication device, wherein the one or more than oneingested IEM comprises the prescribed medication; and wherein thecomputer system is further configured to: determine, based on theingestion data of the patient record, that the prescribed medication hasnot been administered at a prescribed time of the medication schedulethat has passed; and transmit to the electronic communication device,after a designated time period since the passed prescribed time, amessage to remind the patient to administer the prescribed medication.29. The system of claim 28, wherein the patient record of the computersystem further indicates: attestation data received via the patientinput device, wherein the attestation data comprises at least oneattestation associated with an administered medication; and wherein thecomputer system is further configured to: determine, based on theattestation data, that the prescribed medication has not beenadministered at the prescribed time of the medication schedule that haspassed.
 30. The system of claim 21, wherein the patient record furtherindicates: a prescribed behavior of the patient, wherein the prescribedbehavior is associated with a behavior schedule including prescribedtimes to perform or to avoid the prescribed behavior; and attestationdata received via the patient input device, wherein the attestation datacomprises at least one attestation associated with a behavior performedor a behavior avoided; and wherein the computer system is furtherconfigured to: determine, based on the attestation data, that theprescribed behavior has not been attested to at a prescribed time of thebehavior schedule that has passed; and transmit to the electroniccommunication device, after a designated time period since the passedprescribed time, a message to remind the patient to perform or to avoidthe prescribed behavior.
 31. The system of claim 21, wherein theelectronic communication device is further configured to communicate theselected therapeutic recommendation to the patient.
 32. The system ofclaim 21, wherein the therapeutic recommendation is selected from thegroup consisting essentially of a medicine prescription adjustment, ameditation practice, a relaxation practice, a physical exercise, aperiod of sleep, a procedural change, a therapy change and a dietaryadjustment.
 33. The system of claim 21, wherein the physiological datacomprises at least one of a heart rate, a blood pressure, a respirationrate, a respiration intensity, or electrical skin conductivity.
 34. Thesystem of claim 21, wherein the therapeutic recommendation is furtherselected based at least partly on genetic information descriptive of thepatient.
 35. The system of claim 21, wherein the therapeuticrecommendation is further selected based at least partly on additionalpatient information selected from the group consisting essentially oflifestyle data, patient adherence information, behavioral information,emotional information and diagnostic test information.
 36. A system,comprising: a sensor coupled to a body of a patient, wherein the sensoris configured to detect physiologic data from the body of the patient; amobile device associated with the patient, wherein the mobile devicecomprises a patient data input device; and a computer systemcommunicatively coupled to the mobile device, wherein the computersystem comprises: a patient record associated with the patient, whereinthe patient record indicates: patient data comprising a plurality ofpatient activities; and detected physiological data received from thesensor via the mobile device; wherein the computer system is configuredto: identify an unhealthy physiological data value from the detectedphysiological data of the patient record; correlate the unhealthyphysiological data value to a patient activity of the patient data;select a therapeutic recommendation to address the unhealthyphysiological data value; and transmit the selected therapeuticrecommendation to the patient, via the mobile device, at a future timeassociated with the patient activity correlated to the unhealthyphysiological data value.
 37. The system of claim 36, wherein theplurality of patient activities are associated with at least one of awork task, a physical exercise, a stress inducing event, a hobby, arecreational activity, a meal consumption, a liquid ingestion, a socialinteraction, or an erotic act.
 38. The system of claim 36, wherein thecomputer system is further configured to: compare the detectedphysiological data to the plurality of patient activities of the patientdata to identify patterns between unhealthy physiological data valuesand routine activities of the patient; and transmit a therapeuticrecommendation to the patient, via the mobile device, prior to a routineactivity having an identified pattern to an unhealthy physiological datavalue.
 39. The system of claim 36, further comprising: a plurality ofingestible event markers (IEMs), wherein each IEM is stably associatedwith a medication, wherein each IEM is configured to generate ingestiondata and wirelessly transmit the ingestion data after contact withbodily fluid of the patient at a target physiological site, and whereinthe ingestion data comprises an identification of the medication and atime of the ingestion; wherein the patient record of the computer systemfurther indicates: a prescribed medication of the patient, wherein theprescribed medication is associated with a medication schedule includingprescribed times to administer the prescribed medication; and ingestiondata received from one or more than one IEM ingested by the patient viathe mobile device, wherein the one or more than one ingested IEMcomprises the prescribed medication; and wherein the computer system isfurther configured to: determine, based on the ingestion data of thepatient record, that the prescribed medication has not been administeredat a prescribed time of the medication schedule that has passed; andtransmit to the mobile device, after a designated time period since thepassed prescribed time, a message to remind the patient to administerthe prescribed medication.
 40. The system of claim 36, wherein thepatient record further indicates: a prescribed behavior of the patient,wherein the prescribed behavior is associated with a behavior scheduleincluding prescribed times to perform or to avoid the prescribedbehavior; and attestation data received via the patient data inputdevice, wherein the attestation data comprises at least one attestationassociated with a behavior performed or a behavior avoided; and whereinthe computer system is further configured to: determine, based on theattestation data, that the prescribed behavior has not been attested toat a prescribed time of the behavior schedule that has passed; andtransmit to the mobile device, after a designated time period since thepassed prescribed time, a message to remind the patient to perform or toavoid the prescribed behavior.